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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 November 2023
• Main ID: NCT03845517
• Date of registration: 15/02/2019
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
• Scientific title: 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)
• Date of first enrolment: April 18, 2019
• Target sample size: 350
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03845517
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Canada, China, Colombia, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Romania, Serbia, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Placebo

Drug: PF-06700841 30 mg

Drug: PF-06700841 45 mg

Drug: PF-06700841 15 mg

Primary Outcome(s)

Proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI-4) at Week 52. [Time Frame: Week 52]

Secondary Outcome(s)

Number of clinically significant abnormalities in clinical laboratory values. [Time Frame: Baseline through Week 56]

Change from baseline in the total scores of the Lupus Quality of Life (LupusQoL) at Week 52. [Time Frame: Baseline, Week 52]

Change from baseline in the total scores of Functional Assessment of Chronic Illness Therapy Fatigue (FACIT F) at Week 52. [Time Frame: Baseline, Week 52]

Number of clinically significant abnormalities in electrocardiograms [Time Frame: Baseline through Week 56]

Proportion of participants achieving the British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52. [Time Frame: Baseline, Week 52]

Number of discontinuations due to AE's [Time Frame: Baseline through Week 56]

Number of treatment emergent adverse events (AE's) [Time Frame: Baseline through Week 56]

Proportion of participants achieving the Lupus Low Disease Activity State (LLDAS) at Week 52. [Time Frame: Baseline, 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 [Time Frame: Baseline, Week 52]

Proportion of participants achieving SRI-4 at Week 52 and have a sustained reduction of prednisone (or equivalent) at Week 52. [Time Frame: Week 52]

Time to first severe flare in PF 06700841 treated participants relative to placebo. [Time Frame: Baseline, Week 52]

Number of clinically significant abnormalities in vital signs [Time Frame: Baseline through Week 56]

Proportion of participants achieving a reduction in prednisone (or equivalent) at Week 52. [Time Frame: Baseline, Week 52]

Secondary ID(s)

2018-004175-12

B7931028

Source(s) of Monetary Support

Please refer to primary and secondary sponsors