Soquelitinib for Eczema

(SIERRA1 Trial)

Overseen By Corvus Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Corvus Pharmaceuticals, Inc.

Must not be taking: Systemic anti-infectives

Disqualifiers: Other skin conditions, Immunodeficiency, Uncontrolled illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 32

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Isin Sinem Bagci, MD

Principal Investigator

Corvus Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 or older and have had Alzheimer's symptoms for at least one year.

My eczema is moderate to severe based on recent doctor assessments.

I am not pregnant or breastfeeding and will use effective birth control if needed.

Exclusion Criteria

I do not have other active skin diseases or infections needing recent systemic treatment.

Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on AD

I have an immune deficiency or a recent serious infection needing treatment.

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 daily for 12 weeks

12 weeks

Weekly visits for the first 2 weeks, then bi-weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up visits at 30, 60, and 90 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• Soquelitinib

How Is the Trial Designed?

Group I: Cohort 3 - Soquelitinib 400 mg once daily Experimental Treatment 2 Interventions

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.

Group II: Cohort 2 - Soquelitinib 200 mg twice daily Experimental Treatment 2 Interventions

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.

Group III: Cohort 1 - Soquelitinib 200 mg once daily Experimental Treatment 2 Interventions

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.

Group IV: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Corvus Pharmaceuticals, Inc.

Lead Sponsor

Trials

9

Recruited

1,100+