Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis

NCT03624127 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: IM011-0462018-001926-25
• Study Type: interventional
• Target: 666
• Locations: 11 countries
• Sites: 165

Brief Summary

The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)

  The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.

  Week 16

• The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)

  PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).

  Baseline and Week 16

Secondary Outcomes (16)

• The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score at Week 16 (PASI 90)

  Baseline and Week 16

• The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 100)

  Baseline and Week 16

• The Number of Participants With a Static Physician's Global Assessment Score of 0 at Week 16 (sPGA 0)

  Week 16

• Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16

  Baseline and Week 16

• Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score 0 at Week 16

  Week 16

Study Arms (3)

BMS-986165

EXPERIMENTAL

Drug: BMS-986165

Placebo

PLACEBO COMPARATOR

Other: Placebo

Apremilast

ACTIVE COMPARATOR

Drug: Apremilast

Interventions

BMS-986165 DRUG

Specified dose on specified days

BMS-986165

Placebo OTHER

Specified dose on specified days

Placebo

Apremilast DRUG

Specified dose on specified days

Apremilast

Eligibility Criteria

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

You may qualify if:

• Plaque psoriasis for at least 6 months
• Moderate to severe disease
• Candidate for phototherapy or systemic therapy

You may not qualify if:

• Other forms of psoriasis
• History of recent infection
• Prior exposure to BMS-986165 or active comparator

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (165)

Achieve Clinical Research

Birmingham, Alabama, 35216, United States

Location

Coastal Clinical Research - Mobile

Mobile, Alabama, 36608, United States

Location

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Synexus - Tucson

Tucson, Arizona, 85741, United States

Location

Hull Dermatology

Rogers, Arkansas, 72758, United States

Location

First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley

Fountain Valley, California, 92708, United States

Location

University California at Irvine Dermatology Clinical Research Center

Irvine, California, 92697, United States

Location

Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Dream Team Clinical Research

Pomona, California, 91767, United States

Location

University Dermatology Group

San Diego, California, 92123, United States

Location

Unison Clinical Trials

Sherman Oaks, California, 91403, United States

Location

New England Research Associates

Bridgeport, Connecticut, 06606, United States

Location

Precision Clinical Research

Davie, Florida, 33328, United States

Location

Indago Research and Health Center

Hialeah, Florida, 33012, United States

Location

LCC Medical Research

Miami, Florida, 33126, United States

Location

International Dermatology Research

Miami, Florida, 33144, United States

Location

Well Pharma Medical Research

Miami, Florida, 33173, United States

Location

Miami Dade Medical Research Institute

Miami, Florida, 33176, United States

Location

San Marcus Research Clinic

Miami Lakes, Florida, 33014, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Olympian Clinical Research

Tampa, Florida, 33614-7118, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409-3401, United States

Location

Hamilton Dermatology

Alpharetta, Georgia, 30022, United States

Location

Healthcare Research Network - Flossmoor

Flossmoor, Illinois, 60402, United States

Location

Springfield Clinic

Springfield, Illinois, 62703, United States

Location

Deaconess Clinic Downtown

Evansville, Indiana, 47708, United States

Location

The Dermatology Center

New Albany, Indiana, 47150, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

The South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Kansas City Dermatology

Overland Park, Kansas, 66215, United States

Location

Dermatology Specialists Research-Kentucky

Louisville, Kentucky, 40241, United States

Location

Clinical Trials of America - Monroe

Monroe, Louisiana, 71201, United States

Location

Etre Cosmetic Dermatology and Laser Center

New Orleans, Louisiana, 70130, United States

Location

ActivMed Practices and Research - Beverly

Beverly, Massachusetts, 01915, United States

Location

DermCare Experts

Quincy, Massachusetts, 02169, United States

Location

David Fivenson MD Dermatology

Ann Arbor, Michigan, 48103, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Associated Skin Care Specialists - Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Forest Hills Dermatology Group

Kew Gardens, New York, 11374, United States

Location

Mount Sinai - Queens

New York, New York, 10023, United States

Location

PMG Research of Charlotte

Charlotte, North Carolina, 28209, United States

Location

Duke University Health System - Duke Clinic

Durham, North Carolina, 27710-4000, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43203, United States

Location

Synexus - Columbus

Columbus, Ohio, 43212, United States

Location

Health Research of Oklahoma

Oklahoma City, Oklahoma, 73103-2433, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223-6683, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Research Center of Reading

Wyomissing, Pennsylvania, 19610, United States

Location

Synexus Clinical Research - Anderson

Anderson, South Carolina, 29621, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

Interspond - Stones River Dermatology - Murfreesboro Office

Murfreesboro, Tennessee, 37129, United States

Location

Westlake Dermatology - Westlake

Austin, Texas, 78746, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, 75246, United States

Location

Austin Institute for Clinical Research - Pflugerville

Pflugerville, Texas, 78660, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78218, United States

Location

Interspond - Acclaim Dermatology

Sugar Land, Texas, 77479, United States

Location

Center for Clinical Studies - Webster

Webster, Texas, 77598, United States

Location

Dermatology Associates of Seattle

Seattle, Washington, 98101, United States

Location

Eastern Washington Dermatology

Walla Walla, Washington, 99362, United States

Location

Kirk Barber Research

Calgary, Alberta, T2G 1B1, Canada

Location

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Wiseman Dermatology Research

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

The Guenther Dermatology Research Centre

London, Ontario, N6A 3H7, Canada

Location

Office of Dr. Arnon Moshe Katz

Newmarket, Ontario, L3Y 6P5, Canada

Location

North Bay Dermatology Centre

North Bay, Ontario, P1B 3Z7, Canada

Location

Institute of Cosmetic and Laser Surgery

Oakville, Ontario, L6J 7W5, Canada

Location

Skin Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

The Centre for Dermatology - Richmond Hill

Richmond Hill, Ontario, L4B 1A5, Canada

Location

XLR8 Medical Research

Windsor, Ontario, N8W 1E6, Canada

Location

Docteur David Gratton Dermatologue

Montreal, Quebec, H3H 1V4, Canada

Location

Siena Medical Research

Montreal, Quebec, H3Z 2S6, Canada

Location

Centre de Recherche Dermatologique du Quebec Metropolitain

Québec, Quebec, G1V 4X7, Canada

Location

Local Institution

Beijing, Beijing Municipality, 100050, China

Location

Local Institution

Wuhan, Hubei, 430030, China

Location

Local Institution

Hangzhou, Zhejiang, 310009, China

Location

Charite Universitatsmedizin Berlin

Berlin, 10117, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Local Institution - 0165

Nagoya, Aichi-ken, 467-8602, Japan

Location

Local Institution - 0181

Toon-Shi, Ehime, 7910295, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

University of Occupational and Environmental Health, Japan

Kitakyushu, Fukuoka, 807-8555, Japan

Location

Sapporo Skin Clinic

Sapporo, Hokkaido, 060-0063, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Local Institution - 0182

Isehara, Kanagawa, 259-1193, Japan

Location

Local Institution - 0169

Yokohama, Kanagawa, 236-0004, Japan

Location

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, 2458575, Japan

Location

Kochi Medical School Hospital

Nakoku, Kochi, 783-8505, Japan

Location

University Hospital - Kyoto Preferctural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

Local Institution - 0166

Matsumoto, Nagano, 3908621, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 7108602, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329-0498, Japan

Location

Teikyo University Hospital

Itabashi-Ku, Tokyo, 173-8606, Japan

Location

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, 173-8610, Japan

Location

The Jikei University Hospital

Minato-ku, Tokyo, 105-8471, Japan

Location

Local Institution - 0188

Shinagawa, Tokyo, 141-8625, Japan

Location

Local Institution - 0108

Shinjuku, Tokyo, 169-0073, Japan

Location

Local Institution - 0175

Shinjuku-Ku, Tokyo, 160-0023, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Local Institution - 0167

Osaka, 545-8586, Japan

Location

Local Institution - 0160

Osaka, 550-0006, Japan

Location

Local Institution - 0191

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

Local Institution - 0201

Bialystok, 15-077, Poland

Location

Local Institution - 0144

Gdynia, 81-537, Poland

Location

Synexus - Katowice

Katowice, 40-040, Poland

Location

Local Institution - 0079

Krak, 30-510, Poland

Location

Centrum Terapii Wspolczesnej

Lodz, 90-242, Poland

Location

Centrum Medyczne All-Med

Lodz, 94-048, Poland

Location

Miejski Szpital Zespolony w Olsztynie

Olsztyn, 10-229, Poland

Location

DermoDent - Centrum Medyczne Czajkowscy

Osielsko, 86-031, Poland

Location

Solumed Centrum Medyczne

Poznan, 60-529, Poland

Location

Local Institution - 0200

Poznan, 60-773, Poland

Location

Clinical Research Group

Warsaw, 01-142, Poland

Location

Center for Clinical Studies - Texas Medical Center

Wroclaw, 50-367, Poland

Location

Lukasz Matusiak 4health

Wroclaw, 50-566, Poland

Location

dermMedica Sp. z o.o.

Wroclaw, 51-318, Poland

Location

Local Institution - 0203

Wroclaw, 51-685, Poland

Location

Azbuka Zdorovya Medical Center

Kazan', 42011, Russia

Location

Local Institution - 0172

Krasnodar, 350020, Russia

Location

Local Institution - 0140

Moscow, 101000, Russia

Location

Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov

Moscow, 111398, Russia

Location

State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary

Ryazan, 390046, Russia

Location

Clinic of Skin Diseases of Pierre Wolkenstein

Saint Petersburg, 191123, Russia

Location

Polyclinic of Private Security Personnel

Saint Petersburg, 192007, Russia

Location

Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology

Saint Petersburg, 194021, Russia

Location

Ars Vitae Multidisciplinary Medical Center

Saint Petersburg, 194223, Russia

Location

Klinika Kozhnykh I Venericheskikh Bolezney

Saratov, 410028, Russia

Location

Smolensk State Medical University

Smolensk, 214019, Russia

Location

MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev

Yaroslavl, 150003, Russia

Location

Local Institution - 0131

Yekaterinburg, 620076, Russia

Location

Local Institution

Busan, 49241, South Korea

Location

Local Institution - 0187

Hwaseong-si, 18450, South Korea

Location

Local Institution

Hwaseong-si, 18450, South Korea

Location

Local Institution

Incheon, 21565, South Korea

Location

Local Institution

Seongnam-si, 13620, South Korea

Location

Local Institution

Seoul, 120-752, South Korea

Location

Local Institution

Seoul, 137-701, South Korea

Location

Local Institution

Seoul, 660-702, South Korea

Location

Local Institution - 0121

Alcorcón, 28921, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Universitario Cruces

Barakaldo, 48903, Spain

Location

Hospital del Mar - Parc de Salut Mar

Barcelona, 08003, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario de Fuenlabrada

Madrid, 28942, Spain

Location

Local Institution - 0097

Valencia, 46026, Spain

Location

Local Institution

Kaohsiung City, 81362, Taiwan

Location

Local Institution

Taipei, 10099, Taiwan

Location

Local Institution

Taipei, 11217, Taiwan

Location

MAC Clinical Research - Blackpool

Lancashire, FY2 0JH, United Kingdom

Location

Synexus - Merseyside Clinical Research Centre

Liverpool, L22 0LG, United Kingdom

Location

Guys and Saint Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Synexus - Manchester Clinical Research Centre

Manchester, M15 6SE, United Kingdom

Location

Salford Royal NHS Foundation Trust

Manchester, M6 8HD, United Kingdom

Location

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

MAC Clinical Research - Liverpool

Prescot, L34 1BH, United Kingdom

Location

Related Publications (7)

• Armstrong AW, Warren RB, Sofen H, Spelman L, Linaberry M, Becker B, Jou YM, Daamen C, Kimball AB. Deucravacitinib in Plaque Psoriasis After Inadequate Response to Apremilast: Phase 3 POETYK Analysis. Dermatol Ther (Heidelb). 2025 Dec 5. doi: 10.1007/s13555-025-01606-9. Online ahead of print.

  PMID: 41350512 DERIVED

• Armstrong AW, Kircik L, Stein Gold L, Strober B, De Oliveira CHMC, Vaile J, Jou YM, Daamen C, Scharnitz T, Lebwohl M. Deucravacitinib: Laboratory Parameters Across Phase 3 Plaque Psoriasis Trials. Dermatol Ther (Heidelb). 2025 Apr;15(4):1025-1035. doi: 10.1007/s13555-025-01362-w. Epub 2025 Mar 20.

  PMID: 40113724 DERIVED

• Morita A, Imafuku S, Tada Y, Okubo Y, Habiro K, Tsuritani K, Banerjee S, Hoyt K, Kisa RM, Ohtsuki M. Deucravacitinib in plaque psoriasis: Safety and efficacy through 3 years in Japanese patients in the phase 3 POETYK PSO-1, PSO-4, and LTE trials. J Dermatol. 2025 May;52(5):761-772. doi: 10.1111/1346-8138.17685. Epub 2025 Mar 11.

  PMID: 40066907 DERIVED

• Armstrong AW, Lebwohl M, Warren RB, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp KA, Kisa RM, Vaile J, Berger V, Vritzali E, Hoyt K, Colombo MJ, Scotto J, Banerjee S, Strober B, Thaci D, Blauvelt A. Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials. JAMA Dermatol. 2025 Jan 1;161(1):56-66. doi: 10.1001/jamadermatol.2024.4688.

  PMID: 39602111 DERIVED

• Armstrong AW, Augustin M, Beaumont JL, Pham TP, Hudgens S, Gordon KB, Zhuo J, Becker B, Zhong Y, Kisa RM, Banerjee S, Papp KA. Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials. Dermatol Ther (Heidelb). 2024 Aug;14(8):2235-2248. doi: 10.1007/s13555-024-01224-x. Epub 2024 Jul 30.

  PMID: 39080153 DERIVED

• Armstrong AW, Park SH, Patel V, Nicolas P, Wang WJ, Colombo MJ, Chirikov V. Cumulative Benefit Over 52 Weeks With Deucravacitinib Versus Apremilast in Moderate to Severe Plaque Psoriasis: POETYK PSO-1 Post Hoc Analysis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1891-1899. doi: 10.1007/s13555-024-01201-4. Epub 2024 Jun 22.

  PMID: 38907877 DERIVED

• Armstrong AW, Gooderham M, Warren RB, Papp KA, Strober B, Thaci D, Morita A, Szepietowski JC, Imafuku S, Colston E, Throup J, Kundu S, Schoenfeld S, Linaberry M, Banerjee S, Blauvelt A. Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-1 study): a plain language summary. Immunotherapy. 2023 Aug;15(12):963-973. doi: 10.2217/imt-2023-0061. Epub 2023 May 7.

  PMID: 37150952 DERIVED

Related Links

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

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib; apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 9, 2018
• Study Start: August 7, 2018
• Primary Completion: September 2, 2020
• Study Completion: September 2, 2020
• Last Updated: January 30, 2023
• Results First Posted: January 30, 2023

Record last verified: 2023-01

Locations

GB (7); US (67); ES (7); CN (3); JP (26); PL (16); RU (13); CA (13); DE (2); KR (8); TW (3)