A Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects 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

7 May 2021 → ongoing

Decision date (initial)

2023-07-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2022-502519-13-00

EudraCT number

2019-004879-39

WHO UTN

U1111-1245-3008

ClinicalTrials.gov

NCT04772079

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Pharmacodynamic, Therapy, Pharmacoeconomic, Pharmacogenetic, Efficacy, Pharmacogenomic

Part A: Pharmacokinetics: to evaluate the PK at steady-state of
deucravacitinib in subjects in Cohort 1 (age 12 to <18 years) and Cohort
2 (age 4 to <12 years) with moderate to severe plaque psoriasis
Part B: Efficacy: to evaluate the efficacy of the standard dose of
deucravacitinib vs placebo in subjects in Cohort 1 (age 12 to <18 years)
and Cohort 2 (age 4 to <12 years) with moderate to severe plaque
psoriasis
LTE Period: Safety: to characterize the safety/tolerability of
deucravacitinib in pediatric subjects with moderate to severe plaque
psoriasis

Conditions and MedDRA coding

Moderate to Severe Plaque Psoriasis

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002350-PIP01-18

Plan to share IPD

Yes

IPD plan description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Males and females aged 12 to < 18 years for Cohort 1 and aged 4 to < 12 years for Cohort 2.
2. Diagnosed with stable (defined as no significant flares of disease activity or morphologic changes for 6 months) moderate to severe plaque psoriasis. Moderate to severe psoriasis defined by: (at screening visit and Day 1) Psoriasis Area and Severity Index (PASI) ≥ 12, // static Physician's Global Assessment (sPGA) ≥ 3, // Body Surface Area (BSA) ≥ 10% involvement.
3. Candidates for phototherapy or systemic therapy
4. LTE Period: For both Cohort 1 and Cohort 2, subjects must be willing to participate in the optional LTE period and must have the ability to sign the ICF or give assent as per local laws and regulations.
5. LTE Period: Written permission (informed consent) from parents (both, if required by local law), guardians, or legally acceptable representatives must be obtained and documented according to local laws and regulations
6. LTE Period: Subjects must have completed the Week 52 treatment period in Part A or B of the study.

Exclusion criteria 9

1. Subject has non-plaque forms of psoriasis (e.g. erythrodermic, guttate, inverse or pustular)
2. Subjects weighing < 30 Kg at screening
3. Subject has any of the following TB criteria: a) History of active TB prior to screening visit, regardless of completion of adequate treatment b) Signs or symptoms of active TB during screening as judged by the investigator c) A chest x-ray showing evidence of current active or old active pulmonary TB d) Latent TB infection (LTBI) defined as positive IGRA (QuantiFERON-TB Gold) at screening
4. Received live vaccine within 60 days or plan to receive a live vaccine during the study or plan to receive live vaccine within 60 days of last dose of study medication
5. Currently being treated with biologic agents
6. History of ongoing, chronic or recurrent infectious disease, and opportunistic infection regardless of successfully treatment
7. LTE Period: Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this treatment period, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason
8. LTE Period: Prior permanent discontinuation of study treatment in Part A or B of the study
9. LTE Period: Evidence of active TB

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. PART A: Geometric mean observed average concentration at steady state (Cavg.ss), maximum observed plasma concentration at steady state (Cmax), and trough observed plasma concentration (Ctrough) for deucravacitinib.
2. PART B: 1. Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
3. PART B: 2. Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline
4. LTE Period: 1. AEs and SAEs
5. LTE Period: 2. Monitoring of growth including body weight and height and sexual maturation

Investigational products

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

Test 4

Placebo 4

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 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT Represntative

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT Represntative

Third parties 5

Locations

5 EU/EEA countries · 23 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 133 files

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

Application history

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