Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis

• ClinicalTrials.gov Identifier: NCT03813199
• Recruitment Status: Completed
• First Posted: January 23, 2019
• Results First Posted: April 7, 2022
• Last Update Posted: February 15, 2023
• Sponsor: Abivax S.A.
• Information provided by (Responsible Party): Abivax S.A.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Interventions: Drug: ABX464 50mg; Drug: Matching Placebo; Drug: ABX464 100mg; Drug: Methotrexate
• Enrollment: 60

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Period Title: Overall Study
Started	21	19	20
Completed	18	6	19
Not Completed	3	13	1

Baseline Characteristics

Arm/Group Title		ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate	Total
Arm/Group Description		Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Total of all reporting groups
Overall Number of Baseline Participants		21	19	20	60
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	21 participants	19 participants	20 participants	60 participants
		57.9 (11.4)	54.4 (10.6)	58.6 (11.0)	57.0 (11.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	19 participants	20 participants	60 participants
	Female	15 71.4%	11 57.9%	11 55.0%	37 61.7%
	Male	6 28.6%	8 42.1%	9 45.0%	23 38.3%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants	0 participants
					0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.

Outcome Measures

1. Primary Outcome

Title	Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo
Description	TEAE definition is undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment
Time Frame	through study completion, an average of 15 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Measure Type: Count of Participants; Unit of Measure: Participants
	18 85.7%	18 94.7%	14 70.0%

2. Secondary Outcome

Title	Number of Patients Achieving ACR20 Response
Description	The categorical American College of Rheumatology 20% (ACR20) response is a validated index of rheumatoid arthritis disease activity, defined by the number of patients who achieved at least 20% improvement in the ACR response.
Time Frame	at Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Measure Type: Count of Participants; Unit of Measure: Participants
	9 42.9%	3 15.8%	4 20.0%

3. Secondary Outcome

Title	Number of Patients Achieving ACR20/50/70 Response
Description	Number of patients who achieved at least 20%, 50% or 70% improvement in the American College of Rheumatology (ACR) response.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Measure Type: Count of Participants; Unit of Measure: Participants
ACR20 response	9 42.9%	3 15.8%	4 20.0%
ACR50 response	5 23.8%	2 10.5%	1 5.0%
ACR70 response	4 19.0%	1 5.3%	1 5.0%

4. Secondary Outcome

Title	Change From Baseline in C-reactive Protein (CRP)
Description	Change from baseline in C-reactive protein (CRP) at Week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Mean (Standard Deviation); Unit of Measure: mg/L
	-4.31 (28.83)	0.62 (4.89)	-0.65 (18.74)

5. Secondary Outcome

Title	Number of Patients Achieving DAS28-CRP Response
Description	Number of patients achieving categorical Disease Activity Score (DAS) DAS28-C-Reactive Protein (CRP) [DAS28-CRP] response will be measured as moderate/good European League Against Rheumatism (EULAR) response
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat population

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Measure Type: Count of Participants; Unit of Measure: Participants
	14 66.7%	6 31.6%	8 40.0%

6. Secondary Outcome

Title	Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28]
Description	The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (CRP ), and patient's global assessment of disease activity (PtGA). DAS28-CRP = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.36 Ln [CRP(mg/L)+1] + 0.014 PtGA(VAS100mm) + 0.96 Score scale range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat population

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Mean (Standard Deviation); Unit of Measure: score on a scale
	-1.41 (1.45)	-0.72 (1.13)	-0.60 (0.98)

7. Secondary Outcome

Title	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Description	Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat population

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Mean (Standard Deviation); Unit of Measure: mm/h
	-2.6 (19.3)	-0.3 (6.8)	-2.7 (16.6)

8. Secondary Outcome

Title	Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission
Description	Number of patients achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR]remission, which is defined as DAS2-ESR < 2.6
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat population

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Measure Type: Count of Participants; Unit of Measure: Participants
	2 9.5%	0 0.0%	0 0.0%

9. Secondary Outcome

Title	Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR)
Description	The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (ESR), and patient's global assessment of disease activity (PtGA). DAS28-ESR = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.70 Ln [ESR(mm/h)] + 0.014 PtGA(VAS100mm) Score scale range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. change from baseline at weeks 12: the bigger negative score shows a bigger improvment
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Mean (Standard Deviation); Unit of Measure: mm/h
	-1.43 (1.39)	-0.74 (1.11)	-0.59 (1.00)

10. Secondary Outcome

Title	Change From Baseline in Simplified Disease Activity Index Score (SDAI)
Description	SDAI is a validated index of rheumatoid arthritis disease activity. The SDAI calculation is based on 28 tender and swollen joint counts, C-Reactive Protein (CRP), patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA). SDAI score= tender28 + swollen28 + CRP + (PtGA/10) + (PrGA/10). A moderate activity is defined by a SDAI score >11 to 26 included. A high activity is defined by a SDAI score >26. Change from Baseline: the higher negative number shows a bigger improvment
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat population

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Mean (Standard Deviation); Unit of Measure: score on a scale
	-20.21 (33.27)	-9.37 (14.44)	-7.58 (22.69)

11. Secondary Outcome

Title	Change From Baseline in Clinical Disease Activity Index Score (CDAI)
Description	CDAI is a validated index of rheumatoid arthritis disease activity. The CDAI calculation is based on 28 tender and swollen joint counts, patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA). CDAI score= tender28 + swollen28 + (PtGA/10) + (PrGA/10). A moderate activity is defined by a CDAI score >10 to 22 included. A high activity is defined by a CDAI score >22. Change from Baseline: the higher negative number shows a bigger improvment
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat population

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Mean (Standard Deviation); Unit of Measure: score on a scale
	-15.89 (13.29)	-9.99 (15.85)	-6.93 (10.13)

12. Secondary Outcome

Title	Number of Patients Achieving Low Disease Activity (LDA)
Description	Number of patients achieving a Low Disease Activity (LDA) which is defined as DAS28-ESR <=3.2
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat population

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Measure Type: Count of Participants; Unit of Measure: Participants
	4 19.0%	2 10.5%	2 10.0%

13. Secondary Outcome

Title	Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission
Description	Number of patients achieving Simplified Disease Activity Score (SDAI) remission, which is considered achieved if the SDAI score ≤ 3.3
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat population

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Measure Type: Count of Participants; Unit of Measure: Participants
	1 4.8%	0 0.0%	0 0.0%

14. Secondary Outcome

Title	Number of Patients Achieving Clinical Disease Activity (CDAI) Remission
Description	Number of patients achieving Clinical Disease Activity (CDAI) remission, which is considered achieved if the CDAI score ≤ 2.8
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat population

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Measure Type: Count of Participants; Unit of Measure: Participants
	3 14.3%	0 0.0%	0 0.0%

15. Secondary Outcome

Title	Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission
Description	The ACR/EULAR boolean-based remission is a validated criteria based on: Tender/painful Joint Count (28), Swollen Joint Count (28), C-Reactive Protein, patient global assessment of disease, All ≤ 1
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat population

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Measure Type: Count of Participants; Unit of Measure: Participants
	1 4.8%	0 0.0%	0 0.0%

16. Secondary Outcome

Title	Change From Baseline in Tender/Painful Joint Count (TJC28)
Description	Change from Baseline in Tender/painful joint count based on 28-joint assessment (TJC28) at Week 12 TJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

intent to treat

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Mean (Standard Deviation); Unit of Measure: joints
	-6.8 (6.4)	-4.1 (6.6)	-2.9 (3.8)

17. Secondary Outcome

Title	Change From Baseline in Swollen Joint Count (SJC)
Description	Change from Baseline in Swollen joint count based on 28-joint assessment (SJC28) at Week 12 SJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Mean (Standard Deviation); Unit of Measure: joints
	-4.4 (4.2)	-3.2 (5.3)	-2.1 (4.2)

18. Secondary Outcome

Title	Change From Baseline in Pain Visual Analog Scale
Description	Change from Baseline in Pain Visual Analog Scale (Pain-VAS) at week 12 The VAS range from 0 to 10 cm (the higher, the more painful) A bigger negative change from baseline shows a bigger improvment
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Mean (Standard Deviation); Unit of Measure: units on a scale
	-2.63 (2.43)	-0.89 (1.97)	-0.78 (2.36)

19. Secondary Outcome

Title	Change From Baseline in Patient Global Assessment of Disease (PtGA)
Description	Change from Baseline in Patient Global Assessment of Disease (PtGA) . This is a patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: a bigger negative number shows a bigger improvment
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.44 (1.92)	-0.89 (1.93)	-0.36 (2.16)

20. Secondary Outcome

Title	Change From Baseline in Investigator Global Assessment of Disease (PrGA)
Description	Change from Baseline in Investigator global assessment of disease (PrGA): investigator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: the higher negative number shows a better improvement
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Mean (Standard Deviation); Unit of Measure: units on a scale
	-3.26 (2.7)	-1.89 (2.95)	-1.63 (2.38)

21. Secondary Outcome

Title	Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Description	Change from Baseline in Health Assessment questionnaire disability index (HAQ-DI) at Week 12 There are 8 sections in this questionnaire: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2. The 8 scores of the 8 sections are summed and divided by the number of section answered. This gives a score range from 0 to 3 (the bigger the worst activity). The change from Baseline: the bigger negative number shows a bigger improvment
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description:	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study	Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Overall Number of Participants Analyzed	21	19	20
Mean (Standard Deviation); Unit of Measure: units on a scale
	-0.4345 (0.6182)	-0.1053 (0.3443)	-0.1813 (0.4824)

Adverse Events

Time Frame	15 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	ABX464 50mg + Methotrexate		ABX464 100mg + Methotrexate		Placebo + Methotrexate
Arm/Group Description	Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study		Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate ABX464 100mg: ABX464 is a new anti-inflammatory drug Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study		Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
All-Cause Mortality
	ABX464 50mg + Methotrexate		ABX464 100mg + Methotrexate		Placebo + Methotrexate
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/21 (0.00%)		0/19 (0.00%)		0/20 (0.00%)
Serious Adverse Events
	ABX464 50mg + Methotrexate		ABX464 100mg + Methotrexate		Placebo + Methotrexate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0.00%)		1/19 (5.26%)		1/20 (5.00%)
Cardiac disorders
Atrial fibrillation † [1]	0/21 (0.00%)	0	1/19 (5.26%)	1	0/20 (0.00%)	0
Infections and infestations
Covid-19 †	0/21 (0.00%)	0	0/19 (0.00%)	0	1/20 (5.00%)	1
† Indicates events were collected by systematic assessment; [1] atrial fibrillation reactive to hypokalemia secondary to diarrhea in the context of study drug treatment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	ABX464 50mg + Methotrexate		ABX464 100mg + Methotrexate		Placebo + Methotrexate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/21 (71.43%)		17/19 (89.47%)		5/20 (25.00%)
Gastrointestinal disorders
nausea †	3/21 (14.29%)	4	9/19 (47.37%)	12	0/20 (0.00%)	0
Diarrhoea †	4/21 (19.05%)	7	7/19 (36.84%)	11	1/20 (5.00%)	1
Abdominal pain upper †	5/21 (23.81%)	6	4/19 (21.05%)	10	1/20 (5.00%)	1
abdominal pain †	2/21 (9.52%)	3	1/19 (5.26%)	1	0/20 (0.00%)	0
Dyspepsia †	1/21 (4.76%)	1	3/19 (15.79%)	3	0/20 (0.00%)	0
Vomiting †	2/21 (9.52%)	2	3/19 (15.79%)	4	0/20 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia †	0/21 (0.00%)	0	2/19 (10.53%)	3	1/20 (5.00%)	1
Rheumatoid arthritis †	2/21 (9.52%)	2	1/19 (5.26%)	1	1/20 (5.00%)	1
Nervous system disorders
Headache †	8/21 (38.10%)	19	10/19 (52.63%)	16	4/20 (20.00%)	6
Respiratory, thoracic and mediastinal disorders
Cough †	2/21 (9.52%)	2	1/19 (5.26%)	1	0/20 (0.00%)	0
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Vice President Clinical Operations
• Organization: Abivax
• Phone: 01 53 83 08 41
• EMail: paul.gineste@abivax.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Daien C, Krogulec M, Gineste P, Steens JM, Desroys du Roure L, Biguenet S, Scherrer D, Santo J, Ehrlich H, Durez P. Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNFalpha therapy: a placebo-controlled phase II study. Ann Rheum Dis. 2022 May 31;81(8):1076-84. doi: 10.1136/annrheumdis-2022-222228. Online ahead of print.

• Responsible Party: Abivax S.A.
• ClinicalTrials.gov Identifier: NCT03813199
• Other Study ID Numbers: ABX464-301
• First Submitted: January 15, 2019
• First Posted: January 23, 2019
• Results First Submitted: February 3, 2022
• Results First Posted: April 7, 2022
• Last Update Posted: February 15, 2023