Clinical Trials in Spain / NCT06979453
Recruiting
Phase 3
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
NCT06979453 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Plaque Psoriasis
Investigational drug(s) / intervention(s)
Deucravacitinib →Placebo
Deucravacitinib: Specified dose on specified days
Placebo: Specified dose on specified days
Study summary
The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis
Eligibility
Inclusion Criteria
* Participants must have stable plaque psoriasis for 6 months or more prior to Screening.
* Participants must have moderate to severe psoriasis defined by:.
i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1.
ii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1.
iii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1.
\- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:.
i) Is not an individual of childbearing potential (IOCBP).
ii) Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.
Exclusion Criteria
* Participants must not weigh \< 30.0 kg at Screening and Day 1.
* Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day 1.
* Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1.
* Participants must not have any untreated bacterial infection within 60 days prior to Day 1.
* Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis).
* Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions.
* Participants must not have 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.
* Participants must not have had any prior exposure to deucravacitinib.
* Participants must not have received any medication that is specifically prohibited.
* Participants must not have a laboratory finding that is exclusionary.
* Participants must not have any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, immunologic, or local active infection/infectious illness) that, in the investigator's judgment or after consultation with the Sponsor's Medical Monitor, will substantially increase the risk to the participant if he or she participates in the study.
* Participants must not have cancer or history of cancer (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
- Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) — At week 16
- Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline — At week 16
Trial sites (132)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0261 | Birmingham | Alabama | Not Yet Recruiting |
| Local Institution - 0041 | Birmingham | Alabama | Not Yet Recruiting |
| Local Institution - 0053 | Phoenix | Arizona | Active Not Recruiting |
| Local Institution - 0025 | Fountain Valley | California | Not Yet Recruiting |
| Center For Dermatology Clinical Research, Inc. | Fremont | California | Recruiting |
| Dermatology Research Associates | Los Angeles | California | Recruiting |
| Northridge Clinical Trials | Northridge | California | Recruiting |
| Local Institution - 0077 | Sacramento | California | Not Yet Recruiting |
| Golden State Dermatology - Walnut Creek - Ygnacio Valley Road | Walnut Creek | California | Recruiting |
| Paradigm Clinical Research, LLC | Wheat Ridge | Colorado | Recruiting |
| Local Institution - 0021 | Clearwater | Florida | Not Yet Recruiting |
| Life Clinical Trials | Margate | Florida | Recruiting |
| Skin Research of South Florida | Miami | Florida | Recruiting |
| Wellness Clinical Research | Miami Lakes | Florida | Recruiting |
| MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research | Tampa | Florida | Recruiting |
| USF Health | Tampa | Florida | Recruiting |
| Dermatology Affiliates Research Institute | Atlanta | Georgia | Recruiting |
| Advanced Medical Research, PC. | Sandy Springs | Georgia | Recruiting |
| Local Institution - 0271 | Ammon | Idaho | Not Yet Recruiting |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | Recruiting |
| Kentucky Advanced Medical Research LLC | Murray | Kentucky | Recruiting |
| Local Institution - 0202 | Metairie | Louisiana | Not Yet Recruiting |
| Dermatology and Skin Cancer Specialists, LLC | Rockville | Maryland | Recruiting |
| Kuchnir Dermatology & Dermatologic Surgery | Milford | Massachusetts | Recruiting |
| C.S. Mott Clinical Research Center (CRC) | Detroit | Michigan | Recruiting |
| Henry Ford Medical Center | Detroit | Michigan | Recruiting |
| Local Institution - 0233 | Columbia | Missouri | Not Yet Recruiting |
| Local Institution - 0278 | Columbia | Missouri | Not Yet Recruiting |
| Dermatology and Skin Cancer Center | Lee's Summit | Missouri | Recruiting |
| JDR Dermatology Research | Las Vegas | Nevada | Recruiting |
| Local Institution - 0283 | Clifton | New Jersey | Not Yet Recruiting |
| Local Institution - 0281 | Robbinsville | New Jersey | Not Yet Recruiting |
| Local Institution - 0273 | Brooklyn | New York | Not Yet Recruiting |
| Local Institution - 0205 | New York | New York | Not Yet Recruiting |
| Local Institution - 0166 | The Bronx | New York | Not Yet Recruiting |
| Local Institution - 0234 | Hickory | North Carolina | Completed |
| Apex Clinical Research Center - Canton | Canton | Ohio | Recruiting |
| Apex Clinical Research Center | Lorain | Ohio | Recruiting |
| Apex Clinical Research Center | Mayfield Heights | Ohio | Recruiting |
| Paddington Testing Company | Philadelphia | Pennsylvania | Recruiting |
+ 92 more sites — see the full list on the official registry below.
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Other trials for the same condition
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06979453 on ClinicalTrials.gov ↗ ← All trials in Spain