A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Psoriatic Arthritis Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04908202
• Other study ID #: IM011-054
• Secondary ID: 2020-005097-10U1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 13, 2021
• Est. completion date: May 12, 2027

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 650
• Est. completion date: May 12, 2027
• Est. primary completion date: September 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.

• Meets the Classification Criteria for Psoriatic Arthritis at Screening.

• Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening.

• Active arthritis as shown by = 3 swollen joints and = 3 tender joints at Screening and day 1.

• Participant has high sensitivity C-reactive protein (hsCRP) = 3 mg/L at Screening.

• = 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading.

• Must have completed the week 52 treatment for the optional open-label long-term extension period.

Exclusion Criteria

• Nonplaque psoriasis at screening or day 1.

• Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis.

• History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).

• Active fibromyalgia.

• Received an approved or investigational biologic therapy for the treatment of PsA or PsO.

• Other protocol-defined Inclusion/Exclusion criteria apply.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis
• Rheumatic Diseases

Intervention

Drug:
• Deucravacitinib
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0169	Buenos Aires
Argentina	Local Institution - 0194	Buenos Aires
Argentina	Local Institution - 0192	Caba	Ciudad Autónoma De Buenos Aires
Argentina	Local Institution - 0213	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Local Institution - 0046	Córdoba	Cordoba
Argentina	Local Institution - 0054	La Plata	Buenos Aires
Argentina	Local Institution - 0193	Mendoza
Argentina	Local Institution - 0215	Quilmes	Ciudad Autónoma De Buenos Aires
Argentina	Local Institution - 0196	Rosario	Santa Fe
Argentina	Local Institution - 0047	San Miguel De Tucuman	Tucuman
Australia	Local Institution - 0137	Botany	New South Wales
Australia	Local Institution - 0136	Camberwell	Victoria
Australia	Local Institution - 0211	Hobart	Tasmania
Australia	Local Institution - 0220	Phillip	Australian Capital Territory
Australia	Local Institution - 0133	Westmead	New South Wales
Australia	Local Institution - 0132	Woolloongabba	Queensland
Brazil	Local Institution - 0214	Curitiba	Paraná
Brazil	Local Institution - 0219	Curitiba	Paraná
Brazil	Local Institution - 0002	Juiz de Fora	Minas Gerais
Brazil	Local Institution - 0005	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0001	Salvador	Bahia
Brazil	Local Institution - 0108	Santo Andre	São Paulo
Brazil	Local Institution - 0109	Vitória	Espirito Santo
Bulgaria	Local Institution - 0253	Burgas
Bulgaria	Local Institution - 0246	Plovdiv
Bulgaria	Local Institution - 0247	Plovdiv
Bulgaria	Local Institution - 0249	Plovdiv
Bulgaria	Local Institution - 0255	Plovdiv
Bulgaria	Local Institution - 0267	Plovdiv
Bulgaria	Local Institution - 0245	Sofia
Bulgaria	Local Institution - 0248	Sofia
Bulgaria	Local Institution - 0259	Sofia
Bulgaria	Local Institution - 0250	Varna
Chile	Local Institution - 0073	Santiago	Metropolitana
Chile	Local Institution - 0099	Santiago	Región Metropolitana De Santiago
Chile	Local Institution - 0111	Santiago	Metropolitana
Chile	Local Institution - 0222	Santiago	Región Metropolitana De Santiago
Chile	Local Institution - 0226	Santiago	Región Metropolitana De Santiago
Chile	Local Institution - 0261	Viña del Mar	Valparaíso
China	Local Institution - 0159	Beijing	Beijing
China	Local Institution - 0190	Chongqing	Chongqing
China	Local Institution - 0150	DaLian	Liaoning
China	Local Institution - 0147	Guangzhou	Guangdong
China	Local Institution - 0149	Hefei	Anhui
China	Local Institution - 0146	Shanghai	Shanghai
China	Local Institution - 0143	Shenzhen	Guangdong
China	Local Institution - 0145	Yiwu	Zhejiang
Colombia	Local Institution - 0072	Barranquilla
Colombia	Local Institution - 0063	Bogota
Colombia	Local Institution - 0069	Bogotá	Cundinamarca
Colombia	Local Institution - 0071	Bucaramanga	Santander
Colombia	Local Institution - 0070	Cali
Colombia	Local Institution - 0064	Medellin
Colombia	Local Institution - 0094	Medellin
Colombia	Local Institution - 0065	Zipaquira
Czechia	Local Institution - 0018	Ostrava
Czechia	Local Institution - 0208	Pardubice
Czechia	Local Institution - 0017	Praha
Czechia	Local Institution - 0225	Praha	Praha 5
Czechia	Local Institution - 0097	Praha 2
Czechia	Local Institution - 0269	Uherske Hradiste	Zlínský Kraj
Czechia	Local Institution - 0202	Zlín	Zlínský Kraj
Finland	Local Institution - 0013	Helsinki
Finland	Local Institution - 0089	Kuopio
Finland	Local Institution - 0119	Turku
France	Local Institution - 0077	Chambray Les Tours
France	Local Institution - 0075	Montpellier
France	Local Institution - 0074	Paris
Hungary	Local Institution - 0023	Budapest
Hungary	Local Institution - 0025	Budapest
Hungary	Local Institution - 0026	Budapest
Hungary	Local Institution - 0142	Budapest
Hungary	Local Institution - 0203	Budapest
Hungary	Local Institution - 0270	Gyula	Békés
Hungary	Local Institution - 0049	Székesfehérvár	Fejér
Hungary	Local Institution - 0068	Zalaegerszeg
Ireland	Local Institution - 0101	Dublin
Ireland	Local Institution - 0102	Dublin
Ireland	Local Institution - 0103	Galway
Ireland	Local Institution - 0104	Manorhamilton	Leitrim
Italy	Local Institution - 0066	Genova
Italy	Local Institution - 0062	Pavia
Italy	Local Institution - 0096	Udine
Italy	Local Institution - 0058	Verona
Mexico	Local Institution - 0060	Chihuahua
Mexico	Local Institution - 0254	Guadalajara	Jalisco
Mexico	Local Institution - 0212	Merida	Yucatán
Mexico	Local Institution - 0061	Mérida	Yucatán
Mexico	Local Institution - 0057	México	Distrito Federal
Mexico	Local Institution - 0209	Mexico City	Distrito Federal
Mexico	Local Institution - 0227	Mexico City	Distrito Federal
Mexico	Local Institution - 0056	Saltillo	Coahuila
Mexico	Local Institution - 0128	San Luis Potosí	SAN LUIS Potosi
Mexico	Local Institution - 0095	Veracruz
Poland	Local Institution - 0114	Bialystok
Poland	Local Institution - 0241	Czestochowa	Slaskie
Poland	Local Institution - 0231	Dabrówka	Wielkopolskie
Poland	Local Institution - 0257	Gdansk	Pomorskie
Poland	Local Institution - 0234	Gdynia	Pomorskie
Poland	Local Institution - 0252	Katowice	Slaskie
Poland	Local Institution - 0140	Krakow
Poland	Local Institution - 0126	Kraków
Poland	Local Institution - 0127	Kraków
Poland	Local Institution - 0229	Kraków	Malopolskie
Poland	Local Institution - 0238	Lodz	Lódzkie
Poland	Local Institution - 0232	Lublin	Lubelskie
Poland	Local Institution - 0233	Nadarzyn	Mazowieckie
Poland	Local Institution - 0206	Nowy Targ	Malopolskie
Poland	Local Institution - 0162	Olsztyn
Poland	Local Institution - 0112	Poznan
Poland	Local Institution - 0113	Poznan
Poland	Local Institution - 0239	Poznan	Wielkopolskie
Poland	Local Institution - 0230	Swidnik	Lubelskie
Poland	Local Institution - 0125	Warszawa
Poland	Local Institution - 0204	Warszawa
Poland	Local Institution - 0205	Warszawa
Poland	Local Institution - 0235	Warszawa	Mazowieckie
Poland	Local Institution - 0243	Warszawa	Mazowieckie
Poland	Local Institution - 0236	Wolomin	Mazowieckie
Poland	Local Institution - 0210	Wroclaw
Poland	Local Institution - 0244	Wroclaw	Dolnoslaskie
Romania	Local Institution - 0012	Brasov
Romania	Local Institution - 0090	Bucharest	Bucure?ti
Romania	Local Institution - 0167	Bucharest
Romania	Local Institution - 0184	Bucharest
Romania	Local Institution - 0263	Bucharest
Romania	Local Institution - 0260	Bucuresti
Romania	Local Institution - 0266	Bucuresti	Bucure?ti
Romania	Local Institution - 0011	Cluj Napoca
Romania	Local Institution - 0258	Craiova
Romania	Local Institution - 0262	Ia?i
Romania	Local Institution - 0265	Ia?i
Romania	Local Institution - 0264	Iasi
Romania	Local Institution - 0010	Râmnicu Vâlcea
Romania	Local Institution - 0091	Timisoara
Russian Federation	Local Institution	Kemerovo
Russian Federation	Local Institution	Korolev
Russian Federation	Local Institution	Saint Petersburg
Russian Federation	Local Institution	Yaroslavl
Spain	Local Institution - 0021	A Coruña
Spain	Local Institution - 0022	Cordoba
Spain	Local Institution - 0019	Madrid
Spain	Local Institution - 0020	Sabadell
Taiwan	Local Institution - 0123	Kaohsiung City
Taiwan	Local Institution - 0122	Tainan
Taiwan	Local Institution - 0121	Tainan City
Taiwan	Local Institution - 0120	Taipei City
Taiwan	Local Institution - 0124	Taoyuan
United Kingdom	Local Institution - 0116	Harlow
United Kingdom	Local Institution - 0106	Southampton	Hampshire
United Kingdom	Local Institution - 0107	Stoke-on-Trent
United States	Local Institution - 0172	Allen	Texas
United States	Local Institution - 0189	Amarillo	Texas
United States	Local Institution - 0181	Beckley	West Virginia
United States	Local Institution - 0087	Boise	Idaho
United States	Local Institution - 0273	Bothell	Washington
United States	Local Institution - 0080	Chicago	Illinois
United States	Local Institution - 0195	Clearwater	Florida
United States	University Hospitals Cleveland Medical Center-Dermatology	Cleveland	Ohio
United States	Local Institution - 0185	Corvallis	Oregon
United States	Local Institution - 0032	Dallas	Texas
United States	Local Institution - 0170	Denver	Colorado
United States	Local Institution - 0198	Detroit	Michigan
United States	Local Institution - 0168	Fontana	California
United States	Local Institution	Fountain Valley	California
United States	Local Institution - 0199	Fullerton	California
United States	Local Institution - 0171	Gainesville	Georgia
United States	Local Institution - 0197	Gilbert	Arizona
United States	Local Institution - 0175	Greenville	South Carolina
United States	Local Institution - 0042	Hagerstown	Maryland
United States	Local Institution - 0036	Jackson	Tennessee
United States	Local Institution - 0188	Jonesboro	Arkansas
United States	Local Institution - 0268	Kalispell	Montana
United States	Arthritis Center of Lexington-Bluegrass Community Research, Inc.	Lexington	Kentucky
United States	Local Institution - 0272	Margate	Florida
United States	Local Institution - 0082	Miami Lakes	Florida
United States	Local Institution - 0028	Middleburg Heights	Ohio
United States	Local Institution - 0182	Oklahoma City	Oklahoma
United States	Local Institution - 0177	Orland Park	Illinois
United States	Local Institution	Palm Desert	California
United States	Local Institution - 0179	Perrysburg	Ohio
United States	Local Institution - 0038	Sacramento	California
United States	Local Institution - 0178	Schaumburg	Illinois
United States	Local Institution - 0201	Springfield	Missouri
United States	Cohen Medical Centers	Thousand Oaks	California
United States	Local Institution	Toms River	New Jersey
United States	Local Institution - 0186	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Chile,  China,  Colombia,  Czechia,  Finland,  France,  Hungary,  Ireland,  Italy,  Mexico,  Poland,  Romania,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response		At week 16
Secondary	Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score		At week 16
Secondary	Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score		At week 16
Secondary	Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response		At week 16
Secondary	Change from baseline in the Short Form-36 Physical Component Survey (SF-36 PCS) score		At week 16
Secondary	Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Leeds Enthesitis Index (LEI)		At week 16
Secondary	Proportion of participants meeting achievement of Minimal Disease Activity (MDA)		At week 16
Secondary	Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score		At week 16
Secondary	Proportion of participants meeting dactylitis resolution at week 16 among the participants with dactylitis at baseline		At week 16
Secondary	Change from baseline in PsA-modified Sharp-van der Heijde (SvdH) score		At week 16
Secondary	Proportion of participants meeting ACR 20 response		Up to 16 weeks
Secondary	Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR 50) response		Up to 16 weeks
Secondary	Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response		Up to 16 weeks
Secondary	Change from baseline in HAQ-DI score		Up to 16 weeks
Secondary	Proportion of participants who achieve a clinically meaningful improvement (= 0.35 improvement from baseline) in HAQ-DI score among participants with a HAQ-DI score = 0.35 at baseline		Up to 16 weeks
Secondary	Proportion of participants with achievement of PASI 75 response		Up to 16 weeks
Secondary	Proportion of participants with achievement of PASI 90 response		Up to 16 weeks
Secondary	Proportion of participants with achievement of PASI 100 response		Up to 16 weeks
Secondary	Change from baseline in the SF-36 PCS score		Up to 16 weeks
Secondary	Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI		Up to 16 weeeks
Secondary	Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)		Up to 16 weeks
Secondary	Proportion of participants meeting achievement of MDA		Up to 16 weeks
Secondary	Change from baseline in SF-36 Mental Component Summary (MCS) score		Up to 16 weeks
Secondary	Change from baseline in FACIT-Fatigue score		Up to 16 weeks
Secondary	Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline		Up to 16 weeks
Secondary	Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 score		Up to 16 weeks
Secondary	Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score		Up to 16 weeks
Secondary	Proportion of participants with achievement of DAPSA low disease activity response		Up to 16 weeks
Secondary	Proportion of participants with achievement of DAPSA disease remission		Up to 16 weeks
Secondary	Proportion of participants meeting achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 in participants with a baseline PGA-F score of = 3		Up to 16 weeks
Secondary	Change from baseline in DAS28-CRP score		Up to 16 weeks
Secondary	Proportion of participants with achievement of a DAS28-CRP low disease activity response		Up to 16 weeks
Secondary	Proportion of participants with achievement of a DAS28-CRP disease remission		Up to 16 weeks
Secondary	Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)		Up to 16 weeks
Secondary	Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score		Up to 16 weeks
Secondary	Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC)		Up to 16 weeks
Secondary	Proportion of participants meeting achievement of improvement from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score among participants with spondylitis in addition to peripheral joint involvement as their presentation of PsA		Up to 16 weeks
Secondary	Proportion of participants meeting achievement of total PsA-modified SvdH score of = 0		At week 16
Secondary	Proportion of participants meeting achievement of total PsA-modified SvdH score of = 0.5		At week 16
Secondary	Proportion of participants meeting achievement of total PsA-modified SvdH score of = smallest detectable change (SDC)		At week 16
Secondary	Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of = 0		At week 16
Secondary	Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of = 0.5		At week 16
Secondary	Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of = SDC		At week 16
Secondary	Proportion of participants meeting achievement of PsA-modified SvdH joint space narrowing (JSN) score change of = 0		At week 16
Secondary	Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of = 0.5		At week 16
Secondary	Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of = SDC		At week 16
Secondary	Change in PsA-modified SvdH erosion score from baseline		At week 16
Secondary	Change in PsA-modified SvdH JSN score		At week 16
Secondary	Change from baseline in domain scales scores of SF-36		Up to 16 weeks
Secondary	Change from baseline in PCS score of SF-36		Up to 16 weeks
Secondary	Change from baseline in MCS score of SF-36		Up to 16 weeks
Secondary	Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire		Up to 16 weeks
Secondary	Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D) utility scores		Up to 16 weeks
Secondary	Change from baseline in the 5-level EQ-5D-5L utility score subcomponents		Up to 16 weeks
Secondary	Change from baseline in Patient-Reported Outcome Measures Information System (PROMIS) sleep disturbance score (short form)		Up to 16 weeks
Secondary	Incidence of adverse events (AEs)		Up to 156 weeks
Secondary	Incidence of serious adverse events (SAEs)		Up to 156 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting