A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Study Overview
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Brief Summary
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Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.

Official Title
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A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Placebo
* Drug: PF-06700841 15 mg
* Drug: PF-06700841 30 mg
* Drug: PF-06700841 45 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and/or female subjects between ≥18 and ≤75 years of age inclusive. Diagnosis of moderate to severe active Lupus. Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids. Exclusion Criteria: Active renal lupus Severe active central nervous system (CNS) lupus Have cancer or a history of cancer within 5 years of screening. Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus. Active bacterial, viral, fungal, mycobacterial or other infections Psychiatric condition including recent or active suicidal ideation or behavior Have active fibromyalgia/myofascial/chronic pain. Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Experimental: PF-06700841 15 mg<br>PF-06700841 15 mg | Drug: PF-06700841 15 mg<br>* PF-06700841 15 mg<br>|
| Experimental: PF-06700841 30 mg<br>PF-06700841 30 mg | Drug: PF-06700841 30 mg<br>* PF-06700841 30 mg<br>|
| Experimental: PF-06700841 45 mg<br>PF-06700841 45 mg | Drug: PF-06700841 45 mg<br>* PF-06700841 45 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI-4) at Week 52. |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving the British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52. |  | Baseline, Week 52 | 
| Proportion of participants achieving the Lupus Low Disease Activity State (LLDAS) at Week 52. |  | Baseline, Week 52 | 
| Proportion of participants achieving a reduction in prednisone (or equivalent) at Week 52. |  | Baseline, Week 52 | 
| Proportion of participants achieving SRI-4 at Week 52 and have a sustained reduction of prednisone (or equivalent) at Week 52. |  | Week 52 | 
| Percentage of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) Total Activity Score ≥10 at Baseline with ≥50% Reduction in CLASI-A Total Activity Score |  | Baseline, Week 52 | 
| Change from baseline in the total scores of Functional Assessment of Chronic Illness Therapy Fatigue (FACIT F) at Week 52. |  | Baseline, Week 52 | 
| Change from baseline in the total scores of the Lupus Quality of Life (LupusQoL) at Week 52. |  | Baseline, Week 52 | 
| Time to first severe flare in PF 06700841 treated participants relative to placebo. |  | Baseline, Week 52 | 
| Number of treatment emergent adverse events (AE's) |  | Baseline through Week 56 | 
| Number of discontinuations due to AE's |  | Baseline through Week 56 | 
| Number of clinically significant abnormalities in vital signs |  | Baseline through Week 56 | 
| Number of clinically significant abnormalities in electrocardiograms |  | Baseline through Week 56 | 
| Number of clinically significant abnormalities in clinical laboratory values. |  | Baseline through Week 56 |