Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD

Conditions

• Atopic Dermatitis
• Atopic Dermatitis Eczema
• Eczema
• Eczema, Atopic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Soquelitinib — DRUG
  Soquelitinib tablets
• Placebo — DRUG
  Soquelitinib matching placebo tablets

Study Details

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

Key Dates

Start date

Feb 28, 2026

Status verified

Mar 2026

Primary completion

Jun 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 12 [ Time Frame: Baseline through Week 12 ]

Central Contacts

• Corvus Clinical Trials
  650-889-4390
  [email protected]

Locations (1)

Find similar trials in South San Francisco, CA

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