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Janus Kinase Inhibitor

Soquelitinib Dose Escalation for Atopic Dermatitis

Phase 1

Recruiting

Research Sponsored by Corvus Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after last intervention administration

Awards & highlights

Study Summary

This trial is testing the safety, side effects, and early effectiveness of a drug called soquelitinib in people with moderate to severe atopic dermatitis (AD).

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the side effects for Soquelitinib are not detailed here, common side effects for drugs treating eczema may include skin irritation, infections, allergic reactions, headache, and cold symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after last intervention administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after last intervention administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after last intervention administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events, changes in laboratory values, vital signs, and electrocardiograms

Secondary outcome measures

To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by change in percent reaching validated Investigator Global Assessment (vIGA) of 0 or 1

To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by percent change in Eczema and Severity Index (EASI)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Soquelitinib Dose EscalationExperimental Treatment1 Intervention

Participants will receive soquelitinib tablets orally at one of four dose levels (100 mg twice daily, 200 mg once daily, 200 mg twice daily, 400 mg once daily) for 28 days

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo tablets orally once daily or twice daily for 28 days

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Corvus Pharmaceuticals, Inc.Lead Sponsor

7 Previous Clinical Trials

877 Total Patients Enrolled

James Rosenbaum, MDStudy DirectorCorvus Pharmaceuticals, Inc.

2 Previous Clinical Trials

355 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"As per clinicaltrials.gov, this investigation is presently enrolling participants. Originally shared on April 1st, 2024, the latest update was made on April 8th of the same year."

Answered by AI

How large is the participant pool in this research endeavor?

"Affirmative. Data on clinicaltrials.gov shows that this research initiative is actively seeking participants. The trial was initially posted on April 1st, 2024 and last modified on April 8th, 2024. Specifically, the study aims to enroll a total of 64 patients from one designated site."

Answered by AI

What are the safety considerations for patients undergoing Soquelitinib Dose Escalation?

"Our team at Power has assessed the safety of Soquelitinib Dose Escalation to be a 1 on our scale, as this trial falls under Phase 1 where there is minimal data validating both its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD

2024. "Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06345404.

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