A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
Purpose
The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms. This study is seeking for participants who: - are adults of 18 years of age or older. - are confirmed to have CLE or SLE with involvement of the skin. - have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score of at least 8. About 48 participants will be selected to receive active study medicine (PF-06823859) or placebo (an infusion without drug). About 32 are grouped to receive the active study medicine and 16 are to receive placebo. They will be receiving the treatments by intravenous infusion (injected directly into the veins). At week 16 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication. Patients who have received placebo since Day 1 and who have had a clinical response will continue to receive placebo till week 40. All participants will have last follow-up visit at Week 60. The study will compare participants receiving PF-06823859 to participants who receive placebo. This will help us see if PF-06823859 is safe and effective to treat CLE or SLE with skin symptoms and improve participant's CLASI-A score. Participants will take part in this study for about 65 weeks. This includes up to a 5-week selection period, a 12-week Q4Wk treatment period, a 36-week Q8Wk treatment period, and a 12-week follow-up period.
Conditions
- Lupus Erythematosus, Systemic
- Lupus Erythematosus, Cutaneous
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Have a histologically confirmed active CLE or SLE with cutaneous manifestations in the form of subacute cutaneous lupus erythematosus or/and discoid/chronic cutaneous lupus erythematosus at least 3 months and CLASI-A at least 8 or higher. - Participant has adequate intravenous infusion access per investigator's judgement - Willing to comply with study procedures including skin punch biopsies procedures. - Weight is greater than 40 kg and less than 130 kg.
Exclusion Criteria
- Skin disorders other than CLE or SLE. - Active, severe lupus nephritis requiring treatment with cytotoxic agents or high-dose steroids. - Active severe central nervous system lupus requiring therapeutic intervention within 60 days of baseline. - Cancer or a history of cancer within 5 years of screening except adequately resected basal or squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix. - Known history of a major cardiovascular or cerebrovascular event within 24 months, pulmonary arterial hypertension, pulmonary embolism within 6 months of screening. - Have any autoimmune or inflammatory disease that would interfere with interpretation of test results or clinical assessments. - History of disseminated herpes zoster/simplex or recurrent herpes zoster. - Serious infection within 60 days of baseline or an active infection treated with oral antibiotics within 14 days of baseline. - Have evidence of active or latent infection of hepatitis B or C, known history of human immunodeficient virus (HIV) infection, or infected with Mycobacterium TB (active or latent TB) - Laboratory abnormalities that meet exclusion criteria at the Screening visit. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- About 48 eligible participants will be randomized in a 2:1 ratio to receive either PF-06823859 or placebo. Following assessments for the primary endpoint at Week 12, participants who are receiving active PF-06823859 or who are placebo non responders (responder is defined by ≥4 point reduction from the baseline in CLASI-A score) will receive PF-06823859 beginning at Week 16, while placebo responders will continue to be in the placebo group. The last dose of study intervention will be administered at Week 40 followed by last full study assessments at Week 48. The final follow up visit will be conducted at Week 60.
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group 1 |
PF-06823859 |
|
|
Placebo Comparator Group 2 |
Placebo |
|
Recruiting Locations
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Birmingham, Alabama 35249
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- Pfizer