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Taking peoplePhase 2

Soquelitinib for moderate to severe atopic dermatitis (eczema) in adults

Tests soquelitinib against a placebo in adults with moderate to severe atopic dermatitis.

Key facts

Who runs it
Corvus Pharmaceuticals, Inc.
Where
Pardubice I, Prague, and Prague 10, CzechiaSee the 3 sitesAlso in 6 other countries, 34 sites
Registry title
Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD
Status
Recruiting
Phase
Phase 2
People taking part
200 people, planned
Started
Feb 2026
Expected to end
Sept 2027
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Soquelitinib
  • Placebo
Record updated
5 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate to severe atopic dermatitis (eczema) to test soquelitinib against a placebo.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Atopic dermatitis that started at least 1 year ago and is moderate to severe. This means EASI ≥16, body surface area ≥10%, vIGA ≥3 and an average PP-NRS score of ≥4 over the 7 days before Day 1.
Earlier treatment
Must have used a skin cream and/or a systemic treatment for atopic dermatitis within 6 months before randomization.

Main reasons for not taking part

  • Other skin conditions or active skin infections that could affect the assessment of atopic dermatitis
  • Known immunodeficiency syndrome, or an invasive infection or other active infection needing systemic anti-infective treatment within 30 days of Baseline
  • Unstable or uncontrolled illness that could affect safety or the results
  • Pregnant or breastfeeding women
  • Women who can have children and do not agree to use highly effective birth control

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 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

Where in Czechia

Also in 6 other countries, 34 sites

  • Pratia Pardubice a.s.Pardubice I, CzechiaNot yet recruiting
  • Praglandia s.r.o.Prague, CzechiaNot yet recruiting
  • Clintrial s.r.o.Prague 10, CzechiaNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 4 groups in the trial

  • Cohort 1 - Soquelitinib 200 mg once dailyTreatment being tested

    Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding.

    Treatment: Soquelitinib and Placebo

  • Cohort 2 - Soquelitinib 200 mg twice dailyTreatment being tested

    Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding.

    Treatment: Soquelitinib and Placebo

  • Cohort 3 - Soquelitinib 400 mg once dailyTreatment being tested

    Participants will take the appropriate combination of soquelitinib and placebo tablets orally in the morning and evening daily for 12 weeks to ensure the proper dose and maintain blinding.

    Treatment: Soquelitinib and Placebo

  • PlaceboPlacebo, for comparison

    Placebo tablets will be taken orally twice daily for 12 weeks.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Soquelitinib for moderate to severe atopic dermatitis (eczema) in adultsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
5 March 2026