Skip to content

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Children and Adolescents from 5 to less than 18 Years of Age with Active Juvenile Psoriatic Arthritis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517262-41-00
Acronym
IM011-1071
Enrollment
29
Registered
2025-02-18
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Psoriatic Arthritis (JPsA)

Brief summary

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., 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.

Detailed description

Evaluating amount of deucravacitinib in the body at week 16., 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, Assessing how many participants find the medicine easy to swallow and taste good at week 16., Assessing how the amount of medicine in the body affects the results at week 16., 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., Evaluating amount of deucravacitinib in the body at week 16., Seeing how many people have a flare-up between weeks 16 to 42., Assessing how many participants find the medicine easy to swallow and taste good at week 16., Assessing how the amount of medicine in the body affects the results at week 16., 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.

Interventions

DRUGdeucravacitinib
DRUGDeucravacitinib placebo 2mg film-coated tablets in sachet

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
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., 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

MeasureTime frame
Evaluating amount of deucravacitinib in the body at week 16., 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, Assessing how many participants find the medicine easy to swallow and taste good at week 16., Assessing how the amount of medicine in the body affects the results at week 16., 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., Evaluating amount of deucravacitinib in the body at week 16., Seeing how many people have a flare-up between weeks 16 to 42., Assessing how many participants f

Countries

Bulgaria, Czechia, Germany, Italy, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026