Phase 2
N=350
A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT03845517 ↗Enrolled (actual)
350
Serious AEs
8.3%
Results posted
Sep 2024
Primary outcome: Primary: Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52 — 64.6; 57.4; 69.7; 66.3 Percentage of participants — p=0.8076
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); PF-06700841 15 mg (Drug); PF-06700841 30 mg (Drug); PF-06700841 45 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52 |
64.6; 57.4; 69.7; 66.3 | 0.8076 |
| SECONDARY Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52 |
43.8; 42.6; 52.5; 53.3 | 0.5950 |
| SECONDARY Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52 |
22.6; 21.3; 35.1; 34.1 | — |
| SECONDARY Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to <=7.5 mg/Day and Sustained for 12 Weeks Prior to Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline |
26.4; 36.4; 37.0; 41.9 | — |
| SECONDARY Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to <=7.5 mg/Day and Sustained for 12 Weeks at Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline |
20.8; 30.3; 32.6; 32.6 | — |
| SECONDARY Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10 |
73.9; 58.3; 77.8; 56.3 | — |
| SECONDARY Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52 |
4.6; 7.4; 5.8; 7.6 | — |
| SECONDARY Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52 |
11.585; 10.892; 12.371; 14.875 | — |
| SECONDARY Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52 |
8.113; 10.469; 7.547; 11.823 | — |
| SECONDARY Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52 |
9.207; 10.935; 8.169; 15.599 | — |
| SECONDARY Change From Baseline in Pain Domain Scores of LupusQoL at Week 52 |
15.065; 15.480; 16.855; 24.418 | — |
| SECONDARY Change From Baseline in Planning Domain Scores of LupusQoL at Week 52 |
14.168; 12.013; 10.335; 20.310 | — |
| SECONDARY Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52 |
10.317; 11.893; 11.701; 16.443 | — |
| SECONDARY Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52 |
12.430; 12.625; 6.494; 15.363 | — |
| SECONDARY Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52 |
12.535; 17.739; 11.560; 18.878 | — |
| SECONDARY Incidence Rate of Severe Flare Event |
8.32; 6.92; 3.24; 6.95 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AE) |
80; 38; 88; 83 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
8; 4; 8; 9 | — |
| SECONDARY Number of Participants With Adverse Events Leading to Discontinuation From Study |
6; 2; 1; 3 | — |
| SECONDARY Number of Participants With Clinically Significant Vital Signs Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
96; 48; 99; 97 | — |
Summary
Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03845517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.