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Tyrosine kinase 2 (TYK2) blocker

Deucravacitinib for Psoriasis

Phase 4
Recruiting
Led By Raymond Cho, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Patients with moderate-severe psoriasis (BSA >= 10%, PASI >=12, static Physician's Global Assessment (sPGA) 3 and above)
Must not have
Active systemic malignancy
Tuberculosis or other active serious infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment, 4 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial looks at how psoriasis patients' skin & blood cell health is affected by a new drug.

Who is the study for?
Adults with moderate to severe psoriasis (covering at least 10% of their body, with a severity score of 12 or more) can join this trial. They shouldn't have tuberculosis, serious infections, be pregnant or breastfeeding, have used immunosuppressives recently, suffer from severe immune system problems, or any condition that might risk safety or data quality.
What is being tested?
The trial is testing deucravacitinib's effect on skin and blood immune cells in psoriasis patients. It involves taking the TYK2 inhibitor deucravacitinib and monitoring how it changes the function of these cells before and after treatment starts.
What are the potential side effects?
Deucravacitinib may cause side effects such as increased risk of infections due to its action on the immune system. Specific side effects are not listed but generally relate to its role in altering immune cell functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My psoriasis is severe, covering more than 10% of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an active cancer that is affecting my whole body.
Select...
I do not have tuberculosis or any serious infection.
Select...
I have not taken any immunosuppressive drugs in the last 12 weeks.
Select...
I have a severe immune system problem.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment, 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment, 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Psoriasis Area and Severity Index (PASI) score

Side effects data

From 2022 Phase 3 trial • 220 Patients • NCT04167462
18%
Upper respiratory tract infection
8%
Mouth ulceration
7%
Nasopharyngitis
5%
Pruritus
5%
Headache
3%
Folliculitis
3%
Psoriasis
1%
Pharyngitis
1%
Cholecystitis
1%
Gastroenteritis
1%
Gastroenteritis shigella
1%
Diabetes mellitus
1%
Accidental overdose
1%
Hepatobiliary procedural complication
1%
Psoriatic arthropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Week 0 up to Week 16
BMS-986165 Week 0 up to Week 52
BMS-986165 Week 16 up to Week 52

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: deucravacitinib treatmentExperimental Treatment1 Intervention
treatment with deucravacitinib for 6 months

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,588 Previous Clinical Trials
14,900,982 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,688 Previous Clinical Trials
4,096,782 Total Patients Enrolled
Raymond Cho, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
42 Total Patients Enrolled

Media Library

deucravacitinib (Tyrosine kinase 2 (TYK2) blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05858645 — Phase 4
Plaque Psoriasis Research Study Groups: deucravacitinib treatment
Plaque Psoriasis Clinical Trial 2023: deucravacitinib Highlights & Side Effects. Trial Name: NCT05858645 — Phase 4
deucravacitinib (Tyrosine kinase 2 (TYK2) blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05858645 — Phase 4
~14 spots leftby Jun 2026
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