Atopic Dermatitis study: Soquelitinib
Official title Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD
ClinicalTrials.gov ID: NCT07441395
What this study is testing
What is Soquelitinib?
an investigational oral tablet being studied as a potential treatment for atopic dermatitis
Also referred to as CPI-818.
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
- The study aims to find out how well soquelitinib works and how safe it is compared with a placebo in people with atopic dermatitis.
- Who it's for
- Adults who have moderate to severe atopic dermatitis (eczema).
- What's involved
- Participants will take a daily pill of soquelitinib or a placebo for 12 weeks and have clinic visits for skin checks, safety labs, and questionnaires.
- Time commitment
- The trial lasts about 6 months, with weekly visits for the first 2 weeks, then every 2 weeks, plus follow‑up visits at 30, 60, and 90 days after the last dose.
- Phase 2: a mid-size study of how well it works
- 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 18 and older
You may be able to join if
- Adult male or female, ≥18 years of age, as applicable according to local legislation, at Screening.
- Diagnosis of AD with onset of symptoms at least 1 year prior to the Screening visit.
- EASI ≥16
- Body surface area ≥10%
- vIGA ≥3
You likely can't join if
- Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on AD.
- Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit or that...
- Known immunodeficiency syndrome, history of an invasive infection or active non skin-related infection requiring systemic anti-infective treatment...
- History of immunosuppression not related to medication, history of clinically significant medical conditions, or any other reason which in the...
- Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular, respiratory, gastrointestinal, endocrine, hematologic...
See the full eligibility criteria
- Adult male or female, ≥18 years of age, as applicable according to local legislation, at Screening.
- Diagnosis of AD with onset of symptoms at least 1 year prior to the Screening visit.
- EASI ≥16
- Body surface area ≥10%
- vIGA ≥3
- PP-NRS average score of ≥4 over a period of 7 days prior to randomization at Day 1.
- Documented history of prior topical and/or systemic therapy for AD within 6 months of randomization.
- A female participant is eligible if she is not pregnant or breastfeeding, and is either of non-childbearing potential, OR of childbearing potential and agrees to use highly effective birth control
- Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on AD.
- Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit or that could interfere with the appropriate assessment of AD lesions.
- Known immunodeficiency syndrome, history of an invasive infection or active non skin-related infection requiring systemic anti-infective treatment within 30 days of Baseline.
- History of immunosuppression not related to medication, history of clinically significant medical conditions, or any other reason which in the opinion of the investigator would interfere with the participant's...
- Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular, respiratory, gastrointestinal, endocrine, hematologic, or neurologic disorders that would potentially affect participant...
The study team makes the final eligibility decision.
Where it is enrolling
- South San Francisco, California, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at South San Francisco, California, 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.