Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

NCT03881059 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IM011-0842018-004293-10
• Study Type: interventional
• Target: 203
• Locations: 9 countries
• Sites: 94

Brief Summary

The main purpose of study is to assess the dose-response relationship of BMS-986165 (Dose A or Dose B once daily \[QD\]) at Week 16 in the treatment of participants with active PsA.

Conditions

Active Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16

  A participant is considered an ACR 20 responder if the following three conditions are met: 1) ≥ 20% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 20% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 20% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)

  16 weeks after first dose

Secondary Outcomes (35)

• Adjusted Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)

  From baseline (day of the first dose) to 16 weeks after first dose

• Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 75 Response

  16 weeks after first dose

• Adjusted Change From Baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire

  From baseline (day of the first dose) to 16 weeks after first dose

• Percentage of Participants Achieving the American College of Rheumatology (ACR) 50 Response at Week 16

  16 weeks after first dose

• Percentage of Participants Achieving the American College of Rheumatology (ACR) 70 Response at Week 16

  16 weeks after first dose

Study Arms (6)

Part A: Placebo

PLACEBO COMPARATOR

Other: BMS-986165 Placebo

Part A: BMS-986165 Dose A

EXPERIMENTAL

Drug: BMS-986165 Dose A

Part A: BMS-986165 Dose B

EXPERIMENTAL

Drug: BMS-986165 Dose B

Part B: Ustekinumab + BMS-986165 Placebo

EXPERIMENTAL

Other: BMS-986165 Placebo; Drug: Ustekinumab

Part B: BMS-986165 Dose A + Ustekinumab Placebo

EXPERIMENTAL

Drug: BMS-986165 Dose A; Other: Ustekinumab Placebo

Part B: BMS-986165 Dose B + Ustekinumab Placebo

EXPERIMENTAL

Drug: BMS-986165 Dose B; Other: Ustekinumab Placebo

Interventions

BMS-986165 Placebo OTHER

Participants will receive BMS-986165 matching placebo QD

Part A: Placebo; Part B: Ustekinumab + BMS-986165 Placebo

BMS-986165 Dose A DRUG

Participants will receive BMS-986165 Dose A QD.

Part A: BMS-986165 Dose A; Part B: BMS-986165 Dose A + Ustekinumab Placebo

BMS-986165 Dose B DRUG

Participants will receive BMS-986165 dose B QD.

Part A: BMS-986165 Dose B; Part B: BMS-986165 Dose B + Ustekinumab Placebo

Ustekinumab DRUG

Participants will receive ustekinumab SQ injection QD.

Part B: Ustekinumab + BMS-986165 Placebo

Ustekinumab Placebo OTHER

Participants will receive ustekinumab SQ matching placebo QD

Part B: BMS-986165 Dose A + Ustekinumab Placebo; Part B: BMS-986165 Dose B + Ustekinumab Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with PsA for at least 6 months before screening, and who meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
• Participants either (i) cannot have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 tumor necrosis factor -inhibitor (TNFi) (TNFi-experienced). Failure is defined as lack of response or loss of response with at least 3 months of therapy with an approved dose of a TNFi, as judged by the investigator. Failure must have occurred at least 2 months prior to Day 1
• Participants have at least 1 confirmed greater than or equal to (\>=) 2 centimeter (cm) lesion of plaque psoriasis at screening
• Participants have active arthritis as shown by a minimum of \>= 3 swollen joints and \>= 3 tender joints (66/68 joint counts) at screening and Day 1
• High sensitivity C-reactive protein (hsCRP) \>= 3milligram per liter (mg/L) at screening
• Women of Childbearing Potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment

You may not qualify if:

• Has non-plaque psoriasis (that is (i.e.), guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at screening or Day 1
• Has any other autoimmune condition such as rheumatoid arthritis, etc. There are exceptions for inflammatory bowel disease or uveitis as follows: currently active disease is excluded but, a history of no longer active disease for at least 12 months (including not being on medication) is allowed
• Has active (i.e. currently symptomatic) fibromyalgia
• History or evidence of active infection and/or febrile illness within 7 days prior to Day 1 (example, bronchopulmonary, urinary, gastrointestinal, etc.)
• History of recent serious bacterial, fungal, or viral infections requiring hospitalization and intravenous (IV) antimicrobial treatment within 90 days prior to screening, or any infection requiring antimicrobial treatment within 15 days prior to Day 1
• History of active tuberculosis (TB) prior to screening visit, regardless of completion of adequate treatment

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (94)

Rheumatology Associates of North Alabama

Huntsville, Alabama, 35801, United States

Location

Medvin Clinical Research - Covina Office

Covina, California, 91722, United States

Location

University of California at San Diego Medical Center

La Jolla, California, 92039, United States

Location

Arthritis & Rheumatic Disease Specialties

Aventura, Florida, 33180, United States

Location

San Marcus Research Clinic

Miami Lakes, Florida, 33014, United States

Location

Omega Research Consultants - Metrowest

Orlando, Florida, 32835, United States

Location

Integral Rheumatology & Immunology Specialists

Plantation, Florida, 33324, United States

Location

BayCare Medical Group

St. Petersburg, Florida, 33705, United States

Location

University of South Florida - Morsani College of Medicine

Tampa, Florida, 33612, United States

Location

Heartland Research Associates - East Wichita

Wichita, Kansas, 67207, United States

Location

Arthritis Center of Lexington

Lexington, Kentucky, 40504, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

Arthritis Associates

Hattiesburg, Mississippi, 39402, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Atlantic Coast Rheumatology

Toms River, New Jersey, 08755, United States

Location

Albuquerque Center for Rheumatology

Albuquerque, New Mexico, 87102, United States

Location

The Center for Rheumatology-Albany

Albany, New York, 12203, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Joint Muscle Medical Care and Research Institute - Lilington Office

Charlotte, North Carolina, 28204, United States

Location

DJL Clinical Research

Charlotte, North Carolina, 28210, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Paramount Medical Research and Consulting

Middleburg Heights, Ohio, 44130, United States

Location

East Penn Rheumatology Associates

Bethlehem, Pennsylvania, 18015, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Low Country Rheumatology

Summerville, South Carolina, 29486, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Office of Ramesh C. Gupta, MD

Memphis, Tennessee, 38119, United States

Location

Pioneer Research Solutions

Cypress, Texas, 77429-5890, United States

Location

Southwest Rheumatology Research

Mesquite, Texas, 75150, United States

Location

Seattle Rheumatology Associates

Seattle, Washington, 98122, United States

Location

Arthritis Northwest Rheumatology

Spokane, Washington, 99204, United States

Location

L.K.N. Arthrocentrum, s.r.o

Hlu?, 748 01, Czechia

Location

CCR Ostrava

Ostrava, 702 00, Czechia

Location

Revmatologie MUDr. Klara Sirova s.r.o.

Ostrava, 702 00, Czechia

Location

Arthrocentrum

Prague, 101 00, Czechia

Location

Revmatologicky Ustav

Prague, 128 00, Czechia

Location

CCR Prague

Prague, 130 00, Czechia

Location

Nuselska Poliklinika

Prague, 140 00, Czechia

Location

Affidea Praha

Praha 11 Chodov, 148 00, Czechia

Location

PV-Medical Services, s.r.o.

Zlín, 760 01, Czechia

Location

Charite Universitatsmedizin Berlin

Berlin, 10117, Germany

Location

Rheumatologische Schwerpunktpraxis PD Dr. med. Brandt Jurgens

Berlin, 12161, Germany

Location

Universitatsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

HRF II - Hamburger Rheuma Forschungszentrum II - MVZ fur Rheumatologie und Autoimmunmedizin Hamburg

Hamburg, 20095, Germany

Location

SMO.MD GmbH

Magdeburg, 39120, Germany

Location

Universitatsmedizin Mannheim

Mannheim, 68167, Germany

Location

Klinikum der Universitat Munchen

München, 80336, Germany

Location

Clinexpert Gyogycentrum

Budapest, 1033, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, 1062, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

CRU Hungary Egeszsegugyi es Szolgaltato Korlatolt Felelossegu Tarsasag

Miskolc, 3529, Hungary

Location

Aranyklinika

Szeged, 6720, Hungary

Location

Csongrad Megyei Dr. Bugyi Istvan Korhaz

Szentes, 6600, Hungary

Location

CMed Rehabilitacios es Diagnosztikai Kozpont

Székesfehérvár, 8000, Hungary

Location

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, 37134, Italy

Location

Osteo-Medic

Bia?ystok, 15-351, Poland

Location

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

Bialystok, 15-077, Poland

Location

ClinicMed Daniluk Nowak Spolka Jawna

Bialystok, 15-879, Poland

Location

Nasz Lekarz Osrodek Badan Klinicznych - Bydgoszcz

Bydgoszcz, 85-068, Poland

Location

Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168, Poland

Location

Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

Elblag, 82-300, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela

Elblag, 82-300, Poland

Location

Malopolskie Badania Kliniczne

Krakow, 30-002, Poland

Location

Grazyna Pulka Specjalistyczny Osrodek All-med

Krak, 30-033, Poland

Location

Pratia MCM Krakow

Krak, 30-510, Poland

Location

AMED Centrum Medyczne

Lodz, 91-363, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej Lecznica Mak-Med Spolka Cywilna

Nadarzyn, 05-830, Poland

Location

Centrum Badan Klinicznych S.C.

Poznan, 60-773, Poland

Location

Ai Centrum Medyczne

Poznan, 61-113, Poland

Location

Nasz Lekarz Przychodnie Medyczne

Torun, 87-100, Poland

Location

Rheuma Medicus Zaklad Opieki Zdrowotnej

Warsaw, 02-118, Poland

Location

Ars Rheumatica - Reumatika Centrum Reumatologii

Warsaw, 02-691, Poland

Location

Centrum Medyczne AMED Warszawa Targowek

Warsaw, 03-291, Poland

Location

WroMedica

Wroclaw, 51-685, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

Chelyabinsk Regional Clinical Hospital

Chelyabinsk, 454076, Russia

Location

Scientific Research Medical Complex

Kazan', 420097, Russia

Location

Medical Center Revma-Med

Kemerovo, 650070, Russia

Location

Clinic on Maroseyka

Moscow, 101000, Russia

Location

Medical Center Health Family

Novosibirsk, 630099, Russia

Location

State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova

Petrozavodsk, 185019, Russia

Location

Clinical Rheumatological Hospital Number 25

Saint Petersburg, 190068, Russia

Location

Polyclinic of Private Security Personnel

Saint Petersburg, 192007, Russia

Location

LLC Medical Consultation and Research Center-Practice

Yarolavl, 150003, Russia

Location

Clinical Hospital named after NA Semashko

Yaroslavl, 150023, Russia

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, 28942, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Corporacio Sanitaria Parc Tauli

Sabadell, 08208, Spain

Location

Hospital Nuestra Senora de la Esperanza

Santiago de Compostela, 15705, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, BD5 0NA, United Kingdom

Location

The Princess Alexandra Hospital NHS Trust

Harlow, CM20 1QX, United Kingdom

Location

Related Publications (4)

• Deodhar A, Nowak M, Ye JY, Lehman T, Banerjee S, Mease PJ. Efficacy and Safety of Deucravacitinib, a Selective, Allosteric TYK2 Inhibitor, by Baseline DMARD Use in a Phase 2 Psoriatic Arthritis Study: A Post Hoc Analysis. Rheumatol Ther. 2025 Oct;12(5):873-887. doi: 10.1007/s40744-025-00776-4. Epub 2025 Jul 5.

  PMID: 40616721 DERIVED

• FitzGerald O, Gladman DD, Mease PJ, Ritchlin C, Smolen JS, Gao L, Hu Y, Nowak M, Banerjee S, Catlett I. Phase 2 Trial of Deucravacitinib in Psoriatic Arthritis: Biomarkers Associated With Disease Activity, Pharmacodynamics, and Clinical Responses. Arthritis Rheumatol. 2024 Sep;76(9):1397-1407. doi: 10.1002/art.42921. Epub 2024 Jul 1.

  PMID: 38770592 DERIVED

• Strand V, Gossec L, Coates LC, Ogdie A, Choi J, Becker B, Zhuo J, Lehman T, Nowak M, Elegbe A, Mease PJ, Deodhar A. Improvements in Patient-Reported Outcomes After Treatment With Deucravacitinib in Patients With Psoriatic Arthritis: Results From a Randomized Phase 2 Trial. Arthritis Care Res (Hoboken). 2024 Aug;76(8):1139-1148. doi: 10.1002/acr.25333. Epub 2024 May 7.

  PMID: 38529674 DERIVED

• Mease PJ, Deodhar AA, van der Heijde D, Behrens F, Kivitz AJ, Neal J, Kim J, Singhal S, Nowak M, Banerjee S. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis. Ann Rheum Dis. 2022 Jun;81(6):815-822. doi: 10.1136/annrheumdis-2021-221664. Epub 2022 Mar 3.

  PMID: 35241426 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigative site staff, the Sponsor, and Participant will remain blinded to treatment assignment with the exception of an unblinded pharmacist, an unblinded study drug administrator (Part B), and an unblinded site monitor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 19, 2019
• Study Start: April 1, 2019
• Primary Completion: April 27, 2020
• Study Completion: January 27, 2021
• Last Updated: February 15, 2022
• Results First Posted: May 17, 2021

Record last verified: 2022-01

Locations

HU (7); GB (2); RU (10); US (31); DE (8); CZ (9); IT (1); ES (6); PL (20)