NCT07441395RecruitingPhase 2
Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Moderate to Severe Atopic Dermatitis (SIERRA1)
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
The main purpose of this study is to see how well different doses of soquelitinib work in participants with atopic dermatitis (AD) as compared to a placebo (pill with no medicine in it). To check this, the study doctors will examine participants' skin regularly to track how their AD changes during the study. The study doctors will see how safe soquelitinib is by tracking side effects among participants. They will also check "tolerability," which means how well the participants can handle soquelitinib and whether any potential side effects are manageable for them. To understand how well soquelitinib works, it will be compared with a placebo. Placebo is a substance that looks like soquelitinib but contains no active medicine in it. Participants will: * Take study treatment (soquelitinib or placebo) every day for 12 weeks * Visit the clinic for check-ups and tests every week for the first 2 weeks then every 2 weeks during the treatment period, and then return for follow-up visits 30, 60, and 90 days after the last dose of study treatment
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 23 Feb 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Corvus Pharmaceuticals, Inc.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07441395
- EU CT number
- 2025-524384-20-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 1 Feb 2026 to the primary completion date, 30 Jun 2027
- 37 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on AD.
Other illness
- 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 participation in this study.
- Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular, respiratory, gastrointestinal, endocrine, hematologic, or neurologic disorders that would potentially affect participant safety within the study or confound efficacy and safety assessments.
Who the study is looking for
- 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.
- Moderate to severe disease at screening and pre-randomization on Day 1 defined by:
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center Medconsult Pleven OOD Coordinator of this site? Confirm its status | Lovech | Bulgaria | Not yet recruiting |
| Medical Center Medconsult Pleven OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Not yet recruiting |
| UNIMED Medical Center EOOD Coordinator of this site? Confirm its status | Sevlievo | Bulgaria | Not yet recruiting |
| Dkc Fokus-5 Lzip OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Not yet recruiting |
| Pratia Pardubice a.s. Coordinator of this site? Confirm its status | Pardubice I | Czechia | Not yet recruiting |
| Praglandia s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Clintrial s.r.o. Coordinator of this site? Confirm its status | Prague 10 | Czechia | Not yet recruiting |
| Universitaetsklinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Not yet recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Not yet recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Not yet recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Not yet recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Not yet recruiting |
| Imed Valencia Coordinator of this site? Confirm its status | Burjassot | Spain | Not yet recruiting |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Not yet recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Not yet recruiting |
| Hospital de Manises Coordinator of this site? Confirm its status | Manises | Spain | Not yet recruiting |
| Hospital Vital Alvarez-Buylla Coordinator of this site? Confirm its status | Mieres | Spain | Not yet recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Not yet recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Not yet recruiting |
| IRCCS Azienda Ospedaliera Metropolitana Coordinator of this site? Confirm its status | Genoa | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Not yet recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Azienda Sanitaria Universitaria Giuliano Isontina Coordinator of this site? Confirm its status | Trieste | Italy | Not yet recruiting |
| Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Not yet recruiting |
| Dermoklinika Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak Coordinator of this site? Confirm its status | Łódź | Poland | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Not yet recruiting |
| Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki Coordinator of this site? Confirm its status | Szczecin | Poland | Not yet recruiting |
| Klinika Ambroziak Dermatologia Coordinator of this site? Confirm its status | Warszawa | Poland | Not yet recruiting |
| OT.Co Zdrowie Sp. z o.o. Coordinator of this site? Confirm its status | Warszawa | Poland | Not yet recruiting |
| dermMedica Sp. z o.o Coordinator of this site? Confirm its status | Wroclaw | Poland | Not yet recruiting |
| Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p Coordinator of this site? Confirm its status | Wroclaw | Poland | Not yet recruiting |
| Corvus Clinical Trials Coordinator of this site? Confirm its status | South San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.