A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.

Phase 2

Recruiting

• Conditions: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous

• Registration Number: NCT05879718
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-5-18
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Have a histologically confirmed active CLE or SLE with cutaneous manifestations in<br> the form of subacute cutaneous lupus erythematosus or/and discoid/chronic cutaneous<br> lupus erythematosus at least 3 months and CLASI-A at least 8 or higher.<br><br> - Participant has adequate intravenous infusion access per investigator's judgement<br><br> - Willing to comply with study procedures including skin punch biopsies procedures.<br><br> - Weight is greater than 40 kg and less than 130 kg.<br><br>Exclusion Criteria:<br><br> - Skin disorders other than CLE or SLE.<br><br> - Active, severe lupus nephritis requiring treatment with cytotoxic agents or<br> high-dose steroids.<br><br> - Active severe central nervous system lupus requiring therapeutic intervention within<br> 60 days of baseline.<br><br> - Cancer or a history of cancer within 5 years of screening except adequately resected<br> basal or squamous cell carcinoma of the skin, or carcinoma in situ of uterine<br> cervix.<br><br> - Known history of a major cardiovascular or cerebrovascular event within 24 months,<br> pulmonary arterial hypertension, pulmonary embolism within 6 months of screening.<br><br> - Have any autoimmune or inflammatory disease that would interfere with interpretation<br> of test results or clinical assessments.<br><br> - History of disseminated herpes zoster/simplex or recurrent herpes zoster.<br><br> - Serious infection within 60 days of baseline or an active infection treated with<br> oral antibiotics within 14 days of baseline.<br><br> - Have evidence of active or latent infection of hepatitis B or C, known history of<br> human immunodeficient virus (HIV) infection, or infected with Mycobacterium TB<br> (active or latent TB)<br><br> - Laboratory abnormalities that meet exclusion criteria at the Screening visit. The<br> above information is not intended to contain all considerations relevant to a<br> patient's potential participation in a clinical trial.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in type 1 IFN GS score in lesional skin at Week 12

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline in CLASI-A score at Week 12;Percent change from baseline in CLASI-A (over time in addition to Week 12);Change from baseline in CLASI-A score (over time);Achieving =50%, 4 or 7 points reduction in CLASI-A (over time);Change from baseline in Physician global assessment (PhGA) (over time);Incidence and severity of laboratory, vital signs, 12-lead ECG abnormalities, AEs, SAEs and withdrawals due to AEs over time