Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD (SIERRA1)

March 3, 2026 updated by: Corvus Pharmaceuticals, Inc.

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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.
  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 - Soquelitinib 200 mg once daily
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.
Drug: Placebo
Soquelitinib matching placebo tablets
Drug: Soquelitinib
Soquelitinib tablets
Other Names:
  • CPI-818
Experimental: Cohort 2 - Soquelitinib 200 mg twice daily
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.
Drug: Placebo
Soquelitinib matching placebo tablets
Drug: Soquelitinib
Soquelitinib tablets
Other Names:
  • CPI-818
Experimental: Cohort 3 - Soquelitinib 400 mg once daily
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.
Drug: Placebo
Soquelitinib matching placebo tablets
Drug: Soquelitinib
Soquelitinib tablets
Other Names:
  • CPI-818
Placebo Comparator: Placebo
Placebo tablets will be taken orally twice daily for 12 weeks.
Drug: Placebo
Soquelitinib matching placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 12
Time Frame: Baseline through Week 12
EASI is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Baseline through Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response of achieving 75% reduction in EASI (EASI75) score at Week 12
Time Frame: Baseline through Week 12
EASI is used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Baseline through Week 12
Response of achieving validated Investigator Global Assessment (vIGA) score of 0 or 1 with reduction from Baseline of ≥2 points at Week 12
Time Frame: Baseline through Week 12
vIGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account. Therapeutic response is a IGA score of 0 (clear) or 1 (almost clear).
Baseline through Week 12
Response of achieving ≥4-point decrease in Peak Pruritus-Numerical Rating Scale (PP-NRS) score at Week 12
Time Frame: Baseline through Week 12
PP-NRS is a validated, single-item, patient-reported outcome of itch severity measured by an 11-point scale for worst itch over the last 24 hours
Baseline through Week 12
Safety and tolerability
Time Frame: Up to 30 days after last intervention administration
Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib compared with placebo, including changes in laboratory values, vital signs, and electrocardiograms (ECGs)
Up to 30 days after last intervention administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corvus Pharmaceuticals, Inc.

Investigators

  • Study Director: Isin Sinem Bagci, MD, Corvus Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPI-818-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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