A Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants with Juvenile Psoriatic Arthritis

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] - Musculoskeletal Diseases [C05]

Trial duration

28 Feb 2025 → ongoing

Decision date (initial)

2025-02-24

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

2024-517262-41-00

WHO UTN

U1111-1311-9059

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Safety, Pharmacokinetic, Therapy

The main goal of this study is to see if deucravacitinib works better than a placebo in kids and teenagers between the ages of 5 and 18 who have Juvenile Psoriatic Arthritis (JPsA).

Secondary objectives 9

1. To understand how deucravacitinib moves in the bodies of these kids and teenagers. This is often called "PK" or pharmacokinetics.
2. To see if a medicine called deucravacitinib works better than placebo using other ways to measure response.
3. To see if the kids and teenagers find the medicine easy to take and if they like the taste of it. This is important because if a medicine doesn't taste good or is hard to take, kids might not want to take it.
4. The relationship between the effects of the medicine and the amount of it in the body. This is often called "E-R" or exposure-response.
5. To make sure that deucravacitinib is safe for kids and teenagers to take and that it doesn't cause any bad side effects. This is what is meant by "safety and tolerability".
6. There are also several other important goals. We want to understand how this medicine moves in the bodies of these kids and teenagers. This is often called "PK" or pharmacokinetics
7. We also want to see if the kids and teenagers find the medicine easy to take and if they like the taste of it. This is important because if a medicine doesn't taste good or is hard to take, kids might not want to take it.
8. We're also interested in the relationship between the effects of the medicine and the amount of it in the body. This is often called "E-R" or exposure-response.
9. Lastly, we want to make sure that deucravacitinib is safe for kids and teenagers to take and that it doesn't cause any bad side effects. This is what we mean by "safety and tolerability".

Conditions and MedDRA coding

Juvenile Psoriatic Arthritis (JPsA)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-002350-PIP02-20

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 Myer 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. Participants need to have been diagnosed with JPsA. This means a participant has arthritis and skin problems like Psoriasis (PsO), or arthritis with other symptoms like swollen fingers or toes (dactylitis), changes in nails, or a close family member with PsO.
2. Participants need to have at least three joints that are affected by arthritis. This could mean that these joints are swollen, painful, or don't move as well as they should.
3. Participants should have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems
4. Participants need to have been diagnosed with JPsA. This means a participant has arthritis and skin problems like Psoriasis (PsO), or arthritis with other symptoms like swollen fingers or toes (dactylitis), changes in nails, or a close family member with PsO.
5. Participants need to have at least three joints that are affected by arthritis. This could mean that these joints are swollen, painful, or don't move as well as they should.
6. Participants should have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems

Exclusion criteria 6

1. Diagnosis of JPsA before 5 years of age, or certain substances in the blood like Antinuclear Antibodies (ANA) or Rheumatoid Factor (RF) above a certain level.
2. Have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA.
3. Have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months
4. Diagnosis of JPsA before 5 years of age, or certain substances in the blood like Antinuclear Antibodies (ANA) or Rheumatoid Factor (RF) above a certain level.
5. Have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA.
6. Have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. To see how long it takes for the first flare-up of the disease to happen between weeks 16 to 42 in participants who take the medication compared to participants who stopped taking the drug.
2. To see how long it takes for the first flare-up of the disease to happen between weeks 16 to 42 in participants who take the medication compared to participants who stopped taking the drug.

Secondary endpoints 10

1. Evaluating amount of deucravacitinib in the body at week 16.
2. Assessing how many participants have a flare-up and how many reach different levels of improvement at weeks 16 and 42. Assessing how much the disease has improved from start of the trial and how many have low disease activity or no disease activity at weeks 16 and 42. Assessing how many participants have no disease activity for at least 6 months in a row. Assessing how many have a 75% improvement in their skin symptoms by week 42
3. Assessing how many participants find the medicine easy to swallow and taste good at week 16.
4. Assessing how the amount of medicine in the body affects the results at week 16.
5. Monitoring any side effects, how severe they are, and if they cause anyone to stop the trial. Assessing how many participants develop an eye condition called uveitis.
6. Evaluating amount of deucravacitinib in the body at week 16.
7. Seeing how many people have a flare-up between weeks 16 to 42.
8. Assessing how many participants find the medicine easy to swallow and taste good at week 16.
9. Assessing how the amount of medicine in the body affects the results at week 16.
10. Monitoring any side effects, how severe they are, and if they cause anyone to stop the trial. Assessing how many participants develop an eye condition called uveitis.

Investigational products

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

Test 3

Placebo 1

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

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 11

Locations

6 EU/EEA countries · 13 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 92 files

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

Application history

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