Soquelitinib for Eczema

Recruiting at 18 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is evaluating a new treatment called soquelitinib for individuals with moderate to severe eczema (also known as atopic dermatitis). The main goals are to determine the drug's safety and its effectiveness in reducing eczema symptoms. Participants will receive either varying doses of soquelitinib or a placebo (a pill with no active drug). Suitable candidates have previously tried other eczema treatments without success or found them difficult to tolerate. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that soquelitinib is likely to be safe for humans?

Research has shown that soquelitinib was safe in earlier studies. Participants generally tolerated soquelitinib well, and no major safety issues emerged. These studies also found a good balance between safety and effectiveness, supporting its further development for atopic dermatitis, a skin condition that causes itchy, inflamed skin.

As this is a Phase 1 trial, the main focus is on safety and tolerability, ensuring the treatment is safe for people. While detailed safety information is still being gathered, early results appear promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard eczema treatments like topical corticosteroids and calcineurin inhibitors, Soquelitinib acts differently by targeting specific immune pathways involved in inflammation. Researchers are excited about Soquelitinib because it offers a novel approach by directly modulating these pathways, potentially leading to reduced symptoms and fewer side effects. This treatment could be a game-changer for patients who struggle with the limitations of current therapies.

What evidence suggests that soquelitinib might be an effective treatment for eczema?

Research has shown that soquelitinib, which participants in this trial may receive, may help treat moderate to severe eczema. In one study, patients who took 200 mg of soquelitinib twice a day experienced faster and more significant symptom improvements compared to those taking different doses. The treatment was also generally safe and well-tolerated. These results suggest that soquelitinib could effectively manage eczema symptoms. ^{2 3 4 5 6}

Who Is on the Research Team?

Suresh Mahabhashyam, MD

Principal Investigator

Corvus Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

investor.corvuspharma.com

investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-full-data-cohort-3-placebo

Press Release

“The complete 28-day data from cohort 3 of our Phase 1 trial of soquelitinib in patients with atopic dermatitis is in-line with the data update ...

2.

corvuspharma.gcs-web.com

corvuspharma.gcs-web.com/news-releases/news-release-details/corvus-pharmaceuticals-provides-business-update-and-reports-24

Press Release - Corvus Pharmaceuticals

Soquelitinib data from cohort 3 of atopic dermatitis Phase 1 clinical trial demonstrates earlier and deeper responses compared to cohorts ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06345404?term=soquelitinib&rank=2

Safety, Tolerability, and Preliminary Efficacy of Soquelitinib ...

To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by change in percent reaching validated Investigator Global ...

4.

investor.corvuspharma.com

investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-data-cohorts-1-3-placebo

Press Release

The data demonstrated a favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 (200 mg twice per day, total daily dose 400 ...

5.

sec.gov

sec.gov/Archives/edgar/data/1626971/000117184325001689/exh_991.htm

Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Data ...

Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Data From Cohorts 1-3 anticipated to be Presented in May. Initial Results From First Two Cohorts ...

6.

investor.corvuspharma.com

investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-interim-data-placebo-controlled

Press Release

The data demonstrated a favorable safety profile and efficacy profile, supporting the ongoing development of soquelitinib for atopic dermatitis.