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A Phase 2 Multicenter Study to Evaluate PF-06823859 in Adult Participants With Active CLE or SLE With Cutaneous Manifestations
EU CTIS ID: 2023-503343-33-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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.
- Known history of HIV based on documented history with positive test, or positive HIV test at screening.
- Have evidence of active or latent infection of hepatitis B or hepatitis C based on screening tests.
- Screening 12-lead ECG that demonstrates clinically significant abnormalities requiring treatment or that are indicative of serious underlying heart disease and other clinically relevant abnormalities which may affect participant safety or interpretation of study results.
- Clinically significant lab abnormalities.
- Investigator or site staff directly involved in the conduct of the study and their family members.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- United States
- Mexico
- Canada
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; United States; Mexico; Canada; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.