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A Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04713072
Recruitment Status : Completed
First Posted : January 19, 2021
Last Update Posted : November 15, 2022
Sponsor:
Information provided by (Responsible Party):
ACELYRIN Inc.

Study Description
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Brief Summary:
This is a Phase II, prospective, multicenter, randomized, double-blind, placebo-controlled, dose finding trial in parallel-groups with primary endpoint at Week 16 (visit V9) to investigate the efficacy, tolerability, safety, pharmacokinetics and immunogenicity of ABY-035 in adult patients with PsA.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Biological: ABY-035 Biological: Placebo Phase 2

Detailed Description:

The study evaluates two dose levels of ABY-035, in comparison to placebo, in subjects with psoriatic arthritis. The clinical trial duration is 72 weeks (Screening - last FU visit) comprised of up to 4 weeks of screening, 44 weeks of double-blind-treatment, and 24 weeks of follow-up.

Treatment Periods are:

  • Treatment Period I: from V1 (Week 0) to V9 (Week 16)
  • Treatment Period II: from V9 (Week 16) to V16 (Week 44: last dosing)

At visit V1 (Week 0), patients who meet the entry criteria will be randomly assigned in equal rates (1:1:1) to one of three parallel groups (A, B, C).

The treatment will be administered once every 2 weeks (Q2W).

Patients assigned to groups A and B will receive active treatment from V1 to V16 (group A = 40 mg ABY-035; group B = 80 mg ABY-035). Patients initially assigned to placebo will switch to active treatment at visit V9 in a blinded fashion (group C = Placebo from V1 to V8 and 80 mg ABY-035 from V9 to V16).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Clinical Trial in Patients With Active Psoriatic Arthritis to Investigate Efficacy, Tolerability, Safety, Pharmacokinetics and Immunogenicity of ABY-035
Actual Study Start Date : August 4, 2020
Actual Primary Completion Date : October 1, 2021
Actual Study Completion Date : January 27, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ABY-035 40 mg
40 mg ABY-035 SC
 Biological: ABY-035
ABY-035 solution for injection
Experimental: ABY-035 80 mg
80 mg ABY-035 SC
 Biological: ABY-035
ABY-035 solution for injection
Placebo Comparator: Placebo
Placebo, switching to 80 mg ABY-035 after 16 weeks
 Biological: Placebo
Placebo to ABY-035 solution for injection


Outcome Measures
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Primary Outcome Measures :
  1. American College of Rheumatology 50 response rate (ACR50) [ Time Frame: 16 weeks ]
    ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo

  2. ACR50 [ Time Frame: 12 weeks ]
    ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo


Secondary Outcome Measures :
  1. ACR20/70 [ Time Frame: 16 weeks ]
    ACR20/70 response rate, percentage of patients achieving Minimal Disease Activity (MDA): at V9 (Week 16) for higher Dose vs. Placebo

  2. ACR20/70 [ Time Frame: 12 weeks ]
    ACR20/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for higher Dose vs. Placebo

  3. ACR20/50/70 [ Time Frame: 16 weeks ]
    ACR20/50/70 response rate, percentage of patients achieving MDA: at V9 (Week 16) for Lower Dose vs. Placebo

  4. ACR20/50/70 [ Time Frame: 12 weeks ]
    ACR20/50/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for Lower Dose vs. Placebo

  5. ACR 20/50/70 [ Time Frame: 8 weeks ]
    ACR 20/50/70 response rate, percentage of patients achieving MDA: at V5 (Week 8) for higher Dose vs. Placebo


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patient who has given his / her signed declaration of consent and data protection declaration
  • At least 18 years and less than 75 years of age at Screening visit
  • Psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of ≥3 points from the five categories of the Classification Criteria for Psoriatic Arthritis (CASPAR) at any timepoint in medical history.
  • Active psoriatic arthritis defined by:
  • ≥3 swollen joints out of 66 joints (SJC66) at Screening visit and Baseline visit
  • ≥3 tender joints out of 68 (TJC68) at Screening visit and Baseline visit
  • Precedent failure or insufficient treatment response to or contraindication or intolerability to nonsteroidal anti-inflammatory drug (NSAID), csDMARD (i.e. MTX, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine A), and/or TNFi (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab)
  • Rheumatoid factor (RF) and anti-CCP antibody negative
  • Presence or history of plaque psoriasis

Exclusion Criteria:

  • Underlying conditions which significantly immunocompromise the patient and / or place the patient at unacceptable risk for receiving an immunomodulatory therapy
  • History of or current relevant autoimmune diseases (e.g. rheumatoid arthritis, primary ankylosing spondylitis, systemic lupus erythematosus) other than psoriasis or psoriatic arthritis
  • History of or current fibromyalgia or pain syndrome
  • Uncontrolled inflammatory bowel disease
  • Presence or history of recurrent or medically important infections in the last 6 months prior to Baseline visit
  • Clinically relevant Candida infection requiring systemic treatment within the last 6 months prior to Baseline visit
  • History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years
  • Insufficiently controlled heart failure
  • Current uncontrolled arterial hyper- or hypotension
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713072


Locations
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Sponsors and Collaborators
ACELYRIN Inc.
Investigators
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Study Director: Apinya Lert, MD ACELYRIN Inc.
More Information
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Responsible Party: ACELYRIN Inc.
ClinicalTrials.gov Identifier: NCT04713072    
Other Study ID Numbers: ABY-035-202
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
 Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases