A Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib (BMS-986165) in Adolescent Participants with Moderate to Severe Plaque Psoriasis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

28 Oct 2025 → ongoing

Decision date (initial)

2025-10-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bristol-Myers Squibb Services Unlimited Company

External identifiers

EU CT number

2023-506296-97-00

WHO UTN

U1111-1289-8030

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Therapy, Safety, Efficacy

Efficacy: to evaluate the efficacy of deucravacitinib vs placebo in participants 12 to < 18 years of age, with moderate to severe plaque psoriasis as assessed by 2 co-primary endpoints:
-PASI 75
-sPGA 0/1

Secondary objectives 3

1. Efficacy: to assess the efficacy of deucravacitinib vs placebo in participants 12 to < 18 years of age with moderate to severe plaque psoriasis using additional endpoints.
2. Evaluate improvement in patient-reported outcomes for deucravacitinib vs placebo.
3. Safety: to evaluate the safety/tolerability of deucravacitinib in participants 12 to < 18 years of age with moderate to severe plaque psoriasis.

Conditions and MedDRA coding

Moderate to Severe Plaque Psoriasis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Subjects 12 to less than 18 years of age
2. Subjects with moderate to severe stable plaque psoriasis for at least 6 months
3. Subjects that are candidates for systemic (whole body) therapy or phototherapy

Exclusion criteria 14

1. Females who are pregnant or breastfeeding
2. Subjects weighing < 30.0 kg at screening
3. Subjects who have non-plaque psoriasis
4. Subjects who have a psoriasis flare or rebound within 4 weeks prior to Screening
5. History or evidence of outpatient active infection and/or febrile illness within 7 days prior to Day 1
6. History of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1
7. Subjects with any untreated bacterial infection within 60 days prior to Day 1
8. Subjects with any ongoing evidence of chronic bacterial infection (e.g., chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis)
9. Herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions
10. Received live vaccines or BCG within 60 days prior to Day 1, or plans to receive a live vaccine during the study, or within 60 days after completing study intervention
11. Prior exposure to deucravacitinib
12. Received medication that is specifically prohibited
13. Subjects that has a laboratory finding that is exclusionary
14. Any major illness/condition or evidence of an unstable clinical condition

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Efficacy: Participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16.
2. Efficacy: Participants achieving a sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16.
3. Safety (LTE): AEs and SAEs through study completion.
4. Safety (LTE): Monitoring of growth, including body weight and height and sexual maturation, through study completion.

Secondary endpoints 8

1. Efficacy: Participants achieving at least 90% improvement in PASI (PASI 90) Week 16.
2. Efficacy: Change from baseline in PASI at Week 16.
3. Efficacy: Change from baseline in BSA involvement at Week 16.
4. Safety: Treatment emergent AEs and SAEs, laboratory parameters, physical examination, and vital signs through study completion.
5. Safety: Participants with protective titers of antibodies to measles, tetanus, and pertussis at Week 16.
6. Safety: Monitoring of growth including body weight and height, and sexual maturation through study completion.
7. Efficacy (LTE): Participants achieving 75% improvement in PASI (PASI 75) over time through study completion.
8. Efficacy (LTE): Participants achieving an sPGA score of 0 (clear) or 1(almost clear) with at least a 2-point reduction from baseline over time through study completion.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254 Blanchardstown Corporate Park 2, Ballycoolin Ballycoolin

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 8

Locations

7 EU/EEA countries · 31 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 145 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications