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Biologic Response Modifier

ESK-001 for Plaque Psoriasis

Phase 2
Waitlist Available
Research Sponsored by Alumis Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and Women must use highly effective methods of contraception for the entirety of the study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years
Awards & highlights

Study Summary

This trial will study long-term effects of a psoriasis treatment on people who participated in a previous trial.

Who is the study for?
This trial is for men and women with plaque psoriasis who have finished a previous study involving ESK-001. Participants must commit to using effective contraception throughout the study. Pregnant individuals or those on certain other medications cannot join.Check my eligibility
What is being tested?
The trial is testing the long-term safety and effectiveness of a medication called ESK-001 in treating plaque psoriasis. It's an open-label extension, meaning everyone knows they're getting ESK-001, and it involves multiple centers.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones for psoriasis treatments may include skin irritation, headaches, fatigue, nausea, and potential risks associated with long-term use which will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I will use effective birth control during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess the safety and tolerability of long-term ESK-001 treatment
Secondary outcome measures
To assess the change in quality of life (QoL) with long-term ESK-001 administration
To assess the long-term efficacy of ESK-001
To assess the pharmacokinetics (PK) of ESK-001 (ctrough)

Trial Design

2Treatment groups
Experimental Treatment
Group I: ESK-001 Dose Level 2Experimental Treatment1 Intervention
ESK-001 administered as an oral tablet
Group II: ESK-001 Dose Level 1Experimental Treatment1 Intervention
ESK-001 administered as an oral tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ESK-001
2022
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

Alumis IncLead Sponsor
5 Previous Clinical Trials
715 Total Patients Enrolled

Media Library

ESK-001 (Biologic Response Modifier) Clinical Trial Eligibility Overview. Trial Name: NCT05739435 — Phase 2
Plaque Psoriasis Research Study Groups: ESK-001 Dose Level 1, ESK-001 Dose Level 2
Plaque Psoriasis Clinical Trial 2023: ESK-001 Highlights & Side Effects. Trial Name: NCT05739435 — Phase 2
ESK-001 (Biologic Response Modifier) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05739435 — Phase 2

Frequently Asked Questions

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

Has the regulatory agency sanctioned ESK-001 Dose Level 1?

"We have assigned ESK-001 Dose Level 1 a score of 2 on the safety scale, as this is only at Phase 2. This implies that while there are some data supporting it's security, none can be found in regards to its efficacy."

Answered by AI

Are there any available slots for enrollees in this experiment?

"According to data on clinicaltrials.gov, this study is not currently recruiting any participants. Despite having been initially posted back in January 17th 2023 and last edited as recent as February 20th of the same year, there are 171 alternative trials that are actively seeking volunteers right now."

Answered by AI

Who else is applying?

What site did they apply to?
Investigator Site #1001
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis
2023. "Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05739435.
All > Psoriasis > Plaque Psoriasis
~137 spots leftby Dec 2026
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