Soquelitinib for Eczema

Recruiting at 16 trial locations

Overseen By Gabriel Luciano

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Corvus Pharmaceuticals, Inc.

Must not be taking: Immunosuppressants, Corticosteroids, JAK inhibitors

Disqualifiers: Psoriasis, Skin infections, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

72 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you may need to stop certain medications. The trial requires that you have not taken oral prednisone or similar drugs within 2 weeks before starting, and other immunosuppressive medications within 4 weeks before starting.

What is the purpose of this trial?

This trial is testing a new drug called Soquelitinib to help people with severe skin problems. It targets those with moderate to severe Atopic Dermatitis and works by blocking a protein that causes inflammation.

Research Team

Suresh Mahabhashyam, MD

Principal Investigator

Corvus Pharmaceuticals, Inc.

Eligibility Criteria

Adults over 18 with moderate to severe atopic dermatitis (eczema) who haven't had success with certain topical or systemic therapies can join. Participants must use contraception and women of childbearing potential must follow specific contraceptive guidance.

Inclusion Criteria

My skin condition has been confirmed as atopic dermatitis by a dermatologist.

My skin condition is moderate to severe, covering more than 10% of my body.

My skin condition didn't improve with certain creams or pills.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive soquelitinib or placebo tablets orally at specified dose levels for 28 days

4 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Soquelitinib

Trial Overview The trial is testing the safety, tolerability, and initial effectiveness of a drug called Soquelitinib compared to a placebo in adults with moderate to severe atopic dermatitis.

Participant Groups

Group I: Soquelitinib Dose Escalation and Dose Expansion Experimental Treatment 1 Intervention

In Dose Escalation, participants will receive soquelitinib tablets orally at one of three dose levels (100 mg twice daily, 200 mg once daily, 200 mg twice daily) for 28 days. In Dose Expansion, participants will receive soquelitinib tablets orally at a dose selected from the dose escalation part of the study, for 56 days

Group II: Placebo Placebo Group 1 Intervention

Participants in the Dose Escalation part of the study will receive placebo tablets orally once daily or twice daily for 28 days. Participants in the Dose Expansion part of the study will receive placebo tablets orally once daily or twice daily for 56 days

Who Is Running the Clinical Trial?

Corvus Pharmaceuticals, Inc.

Lead Sponsor

Trials

9

Recruited

1,100+