A Phase 2 Multicenter Study to Evaluate PF-06823859 in Adult Participants With Active CLE or SLE With Cutaneous Manifestations
- Conditions
- Active Cutaneous Lupus Erythematosus (CLE) or Systemic Lupus Erythematosus (SLE) With Cutaneous ManifestationsMedDRA version: 21.1Level: PTClassification code: 10056509Term: Cutaneous lupus erythematosus Class: 100000004858MedDRA version: 21.1Level: PTClassification code: 10042945Term: Systemic lupus erythematosus Class: 100000004859Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-503343-33-00
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
Male or female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 75 years, inclusive, at the time of signing the ICD., Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures., Participants must be willing to avoid application of topical medications to the index lesions (4 index lesions should be identified at screening and baseline) that are identified for potential biopsies in the study until after Week 32., Participants must have adequate IV access for administration of study intervention and on-study blood sampling., Have a diagnosis of histologically confirmed active CLE or SLE with cutaneous manifestations despite treatment with standard of care medications for at least 12 weeks defined as a score of =8 on the CLASI-A, an erythema score of =2 in the CLASI and historical biopsy (report to be available to disease activity adjudicators) within the past 10 years with either: a. Subacute cutaneous lupus erythematosus, or b. Discoid lupus erythematosus with at least one active discoid lesion (panniculitis, tumidus and chilblain lesions are excluded for the purposes of disease activity qualifying for eligibility and biopsy but are not exclusionary), or c. Both subacute and chronic cutaneous lupus erythematosus, All participants may be currently receiving EITHER a stable dose of an immunosuppressant (MTX, AZA, 6-MP, leflunomide, mizoribine, MMF), or dapsone or colchicine with or without antimalarials and/or corticosteroids, OR anti-malarials (hydroxychloroquine, chloroquine or quinacrine) in combination with corticosteroids (dose of oral corticosteroids must be between 5 and 10 mg/day prednisone equivalent) or permitted topical agents., Participants weighing greater than 40 kg and less than 130 kg and with a BMI of <40 kg/m2.
Have another skin disorder that would confound the results of the skin biopsy or clinical assessments in the study., Significant trauma or major surgery or blood transfusion within 5 weeks of screening, or scheduled to occur during the study, excluding diagnostic surgery., History of alcohol or drug abuse in investigator’s opinion unless in full remission for greater than 12 months prior to first dose of study intervention., History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or recurrent (more than 1 episode within last 5 years) localized, dermatomal herpes zoster., Participants who are currently vaping or using e-cigarettes., Severe active CNS lupus requiring therapeutic intervention within 60 days of Day 1., Cancer or any history of cancer within 5 years of screening (except adequately resected skin basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix without recurrence within the previous 5 years)., History of a major organ transplant or hematopoietic stem cell/marrow transplant or total lymphoid irradiation., Have a history of: •A history of major cardiovascular or cerebrovascular event (stroke) or acute cardiac syndrome (MI, unstable angina pectoris, coronary stenting) within 24 months of screening. •known pulmonary arterial hypertension, •history of pulmonary embolism within 6 months of screening., Preexisting demyelinating disorder such as multiple sclerosis, or other severe neurological deficits., Have any autoimmune or inflammatory disease that would interfere with interpretation of test results or clinical assessments., Screening chest X-ray with changes suggestive of active infection, prior untreated TB, heart failure, suspected malignancy, or any other clinically significant disease in the chest., History of any lymphoproliferative disorder such as EBV related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of lymphoproliferative disease, including lymphadenopathy or splenomegaly., Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation., Have required management of acute or chronic infections., Additional immunomodulatory drug exclusions., Have received plasmapheresis within 12 weeks of screening or IVIg within 24 weeks of screening., Treatment with any investigational drug(s) within 12 weeks of Day 1 for investigational biologics or within one month or 5 half-lives for investigational small molecules whichever is longer, and/or during study participation., Has been exposed to a live vaccine within 8 weeks of Day 1 or are expected to need/receive a live vaccine during the course of the study. Participants should not have received a BCG vaccination within 52 weeks of randomization., Use of filgrastim, pegfilgrastim, erythropoietin or other bone marrow stimulants to improve cell counts within 12-week of screening., Participation in other interventional studies within 12 weeks or 5 half-lives, if known, whichever is longer, prior to study entry and/or during study participation., Participants with a history of hypersensitivity reactions to active drug or any of the excipients in the rug product or placebo., Active, severe lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS., Infected with Mycobacterium TB: active TB or latent TB., K
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of PF 06823859 on the type 1IFN GS score at Week 12 in participants with CLE or SLE with cutaneous manifestations;Secondary Objective: To evaluate the effect of PF 06823859 on the CLASI A score at Week 12 in participants with CLE or SLE with cutaneous manifestations, To evaluate the effect of PF-06823859 on the additional measures of CLASI-A score at Week 12 and over time in participants with CLE or SLE with cutaneous manifestations, To evaluate the effect of PF-06823859 on the PhGA in participants with CLE or SLE with cutaneous manifestations, To evaluate the safety and tolerability of PF-06823859 in participants with CLE or SLE with cutaneous manifestations;Primary end point(s): Change from baseline in type 1 IFN GS score in lesional skin at Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Change from baseline (%) in CLASI A score at Week 12;Secondary end point(s):Percent change from baseline in CLASI-A (over time in addition to Week 12). Change from baseline in CLASI-A (over time). Achieving =50%, 4 or 7 points reduction in CLASI-A (over time);Secondary end point(s):Change from baseline in PhGA (over time);Secondary end point(s):Incidence and severity of laboratory, vital signs, 12-lead ECG abnormalities, AEs, SAEs and withdrawals due to AEs over time