A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus
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|ClinicalTrials.gov Identifier: NCT03161483|
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : July 19, 2019
The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus.
Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.
|Condition or disease||Intervention/treatment||Phase|
|Lupus Erythematosus, Systemic||Drug: CC-220 Other: Placebo||Phase 2|
The study consists of four phases:
- 4-week Screening Phase
- 24-week placebo-controlled phase Subjects will receive either 0.45 mg QD, 0.3 mg QD, 0.15 mg QD or placebo for the first 24 weeks of treatment.
- 28-week active treatment phase At Week 24, all subjects on placebo will be re-randomized to active treatment.
- 52-week long-term extension phase Subjects who complete the treatment phase may be eligible to roll over into a Long-term Extension of up to 52 weeks of treatment.
- 4 - 12-week observational follow-up All subjects who complete 52 weeks of treatment or discontinue the study early will enter a post-treatment observation follow-up phase. The Observational Follow-up Phase will consist of one visit 4 weeks following cessation of study drug for all subjects with an additional 12-week Observational Follow-up visit for males only.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS|
|Actual Study Start Date :||July 6, 2017|
|Estimated Primary Completion Date :||May 20, 2021|
|Estimated Study Completion Date :||September 2, 2021|
Experimental: CC-220 0.45 mg QD Placebo Controlled Phase
Placebo QD PO
Experimental: C-220 0.3 mg QD Placebo Controlled Phase
Placebo QD PO
Experimental: CC-220 0.15 mg QD Placebo Controlled Phase
Placebo QD PO
Placebo Comparator: Placebo
Weeks 0 to 24: CC-220 Placebo Controlled Phase: placebo once daily (QD)
Placebo QD PO
- Proportion of subjects who achieve SRI (4) response- Week 24 [ Time Frame: Week 24 ]
SRI(4) is a composite endpoint, defined by the following criteria:
- Reduction from baseline of ≥ 4 points in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K score and
- No new one or more British Isles Lupus Assessment Group (BILAG) A or new 2 or more BILAG B items compared to baseline using BILAG 2004 Index and
- No worsening from baseline defined by an increase of < 0.30 points from baseline on a Physician's Global Assessment (PGA) visual analog scale (VAS) from 0-3
- Proportion of subjects with SLEDAI 2K score improvement of ≥ 4 points from Baseline [ Time Frame: Weeks 24 ]The SLEDAI 2K score measures disease activity through assessment of 24 lupus manifestations using a weighted score of 1 to 8 points. A manifestation is recorded if it is present over the previous 30 days regardless of severity or whether it has improved or worsened. A SLEDAI 2K score of 3 to 4 points is representative of active disease and a decrease of 1 to 2 points is considered clinically meaningful.
- Proportion of subjects with a ≥ 50% reduction in Cutaneous Lupus Area and Severity Index (CLASI) activity score from baseline, in subjects with Baseline CLASI activity score ≥ 10 [ Time Frame: Weeks 24 ]
The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured
(1=yes; 0=no) and non-scarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together.
- Proportion of subjects with no new organ system affected as defined by 1 or more BILAG A or new 2 or more BILAG B items compared to Baseline using BILAG 2004 Index [ Time Frame: Weeks 24 ]The BILAG 2004 is a composite index that is based on the Classic BILAG index. It is a clinical measure of lupus disease activity. This tool assesses the changing severity of clinical manifestations of SLE using an ordinal scale scoring system that contain 9 systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and hematological). Activity in each organ system is scored as: A=most active disease; B=intermediate activity; C=mild, stable disease; D=previous involvement, currently inactive; E=no previous activity.
- Percentage of subjects with no worsening (increase of <0.30 points from Baseline) in Physician's Global Assessment (PGA) compared to Baseline [ Time Frame: Week 24 ]The PGA uses a visual analog scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none, 1 = mild disease, 2 = moderate disease, and 3 = severe disease.
- Mean change from Baseline in swollen joint count in subjects with ≥ 2 swollen joints at Baseline [ Time Frame: Week 24 ]Joint tenderness and swelling will be noted as "present" or "absent," with no quantitation of severity using a 28- joint count.
- Mean change from Baseline in tender joint count in subjects with ≥ 2 tender joints at Baseline [ Time Frame: Week 24 ]Joint tenderness will be noted as "present" or "absent," with no quantitation of severity using a 28- joint count.
- Mean change from Baseline in PGA score [ Time Frame: Week 24 ]The PGA uses a visual analog scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none, 1 = mild disease, 2 = moderate disease, and 3 = severe disease.
- Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score [ Time Frame: Week 24 ]The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total FACIT-Fatigue score ranges from 0 to 52.
- Corticosteroid Reduction [ Time Frame: Week 24 ]
- The percentage of subjects with a prednisone or equivalent dose of ≥ 10 mg/day at Baseline whose prednisone or equivalent dose has been reduced to ≤ 7.5 mg/day by Week 16 and maintained through Week 24 with no flares between Week 16 and Week 24
- The percentage of subjects with a prednisone or equivalent dose of ≥ 10 mg/day at Baseline whose prednisone or equivalent dose has been reduced to < 10 mg/day by Week 16 and maintained through Week 24 with no flares between Week 16 and Week 24
- Percent change from Baseline in oral corticosteroid (OCS) dose in subjects with prednisone or equivalent ≥ 10 mg/day at Baseline
- The total corticosteroid dose from Baseline through Week 24
- Adverse Event(s) [ Time Frame: UP to approximately 104 weeks ]Number of subjects with adverse event
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): NCT03161483
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
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|Study Director:||Nataliya Agafonova, MD||Celgene Corporation|