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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.
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

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical Center Medconsult Pleven OOD
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LovechBulgariaNot yet recruiting
Medical Center Medconsult Pleven OOD
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PlevenBulgariaNot yet recruiting
UNIMED Medical Center EOOD
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SevlievoBulgariaNot yet recruiting
Dkc Fokus-5 Lzip OOD
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SofiyaBulgariaNot yet recruiting
Pratia Pardubice a.s.
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Pardubice ICzechiaNot yet recruiting
Praglandia s.r.o.
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PragueCzechiaNot yet recruiting
Clintrial s.r.o.
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Prague 10CzechiaNot yet recruiting
Universitaetsklinikum Augsburg
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AugsburgGermanyNot yet recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyNot yet recruiting
Technische Universitaet Dresden
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DresdenGermanyNot yet recruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyNot yet recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyNot yet recruiting
Universitaet Muenster
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MuensterGermanyNot yet recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainNot yet recruiting
Imed Valencia
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BurjassotSpainNot yet recruiting
Hospital Universitario Clínico San Cecilio
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GranadaSpainNot yet recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainNot yet recruiting
Hospital de Manises
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ManisesSpainNot yet recruiting
Hospital Vital Alvarez-Buylla
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MieresSpainNot yet recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainNot yet recruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyNot yet recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyNot yet recruiting
IRCCS Azienda Ospedaliera Metropolitana
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GenoaItalyNot yet recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyNot yet recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyNot yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyNot yet recruiting
Azienda Sanitaria Universitaria Giuliano Isontina
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TriesteItalyNot yet recruiting
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
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CracowPolandNot yet recruiting
Dermoklinika Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak
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ŁódźPolandNot yet recruiting
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
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RzeszówPolandNot yet recruiting
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki
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SzczecinPolandNot yet recruiting
Klinika Ambroziak Dermatologia
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WarszawaPolandNot yet recruiting
OT.Co Zdrowie Sp. z o.o.
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WarszawaPolandNot yet recruiting
dermMedica Sp. z o.o
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WroclawPolandNot yet recruiting
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
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WroclawPolandNot yet recruiting
Corvus Clinical Trials
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South San FranciscoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.