Cutaneous Lupus Erythematosus study: Afimetoran
Official title Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
ClinicalTrials.gov ID: NCT07881120
What this study is testing
What is Afimetoran?
An investigational oral capsule being studied as a potential treatment for cutaneous lupus erythematosus (CLE). It is designed to block toll-like receptors 7 and 8 (TLR7/TLR8).
Also referred to as BLN-256.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if afimetoran improves skin symptoms in people with active lupus that has not responded to standard treatments.
- Who it's for
- Adults with active skin lupus who have not responded to or cannot tolerate standard antimalarial medications.
- What's involved
- Participants take one pill daily for 24 weeks, followed by 28 more weeks of treatment, while continuing their usual lupus care.
- Time commitment
- The study lasts 52 weeks and requires regular visits to the clinic for check-ups and tests.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Adults aged ≥18 years (or ≥16 years where permitted).
- Histologically confirmed active cutaneous lupus erythematosus (CLE) with or without systemic manifestations.
- Active subacute and/or chronic cutaneous lupus erythematosus, including discoid lupus erythematosus.
- Moderate to severe skin disease activity.
- Refractory, intolerant, or inadequately controlled on antimalarial therapy.
You likely can't join if
- Severe lupus nephritis or severe neuropsychiatric SLE
- Drug-induced lupus
- Active or chronic clinically significant infections, including HIV, hepatitis B, hepatitis C, active tuberculosis, untreated latent tuberculosis, or...
- Significant concurrent autoimmune disease other than lupus-related conditions permitted by the protocol
- Active malignancy or recent history of certain cancers
- Other dermatologic conditions that may interfere with study assessments
See the full eligibility criteria
- Adults aged ≥18 years (or ≥16 years where permitted).
- Histologically confirmed active cutaneous lupus erythematosus (CLE) with or without systemic manifestations.
- Active subacute and/or chronic cutaneous lupus erythematosus, including discoid lupus erythematosus.
- Moderate to severe skin disease activity.
- Refractory, intolerant, or inadequately controlled on antimalarial therapy.
- Willing and able to comply with study requirements.
- Agreement to protocol-specified contraception requirements
- Severe lupus nephritis or severe neuropsychiatric SLE
- Drug-induced lupus
- Active or chronic clinically significant infections, including HIV, hepatitis B, hepatitis C, active tuberculosis, untreated latent tuberculosis, or uncontrolled congestive heart failure
- Significant concurrent autoimmune disease other than lupus-related conditions permitted by the protocol
- Active malignancy or recent history of certain cancers
- Other dermatologic conditions that may interfere with study assessments
- Recent use of prohibited medications or investigational therapies
- Prior treatment with afimetoran or another TLR7/TLR8 antagonist
- Clinically significant laboratory abnormalities or severe organ dysfunction
- Pregnancy or breastfeeding
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
- DeBary, Florida, United States
- Missoula, Montana, United States
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, but 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, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States; DeBary, Florida, United States; Missoula, Montana, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.