Psoriatic Arthritis Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
| Verified date | February 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.
| Status | Active, not recruiting |
| Enrollment | 700 |
| Est. completion date | November 12, 2026 |
| Est. primary completion date | February 6, 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 (CASPAR) criteria 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 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich | Buenos Aires | |
| Argentina | Local Institution - 0037 | Buenos Aires | |
| Argentina | Local Institution - 0039 | Caba | Distrito Federal |
| Argentina | Local Institution - 0168 | Cordoba | |
| Argentina | Local Institution - 0048 | La Plata | Buenos Aires |
| Argentina | Local Institution - 0038 | San Isidro | Buenos Aires |
| Argentina | Local Institution - 0171 | San Miguel de Tucumán | Tucuman |
| Australia | Local Institution - 0003 | Botany | New South Wales |
| Australia | Emeritus Research | Camberwell | Victoria |
| Australia | Local Institution - 0017 | Geelong | Victoria |
| Australia | Local Institution - 0004 | Maroochydore | Queensland |
| Australia | BJC Health | Paramatta | New South Wales |
| Australia | Local Institution - 0099 | Woodville | South Australia |
| Belgium | Local Institution - 0078 | Brussels | |
| Belgium | Local Institution - 0058 | Gent | |
| Belgium | Local Institution - 0104 | Leuven | |
| Belgium | Local Institution - 0061 | Liège | |
| Canada | Local Institution - 0006 | Hamilton | Ontario |
| Canada | Local Institution - 0030 | Markham | Ontario |
| Canada | Local Institution - 0001 | Quebec | |
| Canada | Local Institution - 0036 | Toronto | Ontario |
| Canada | Local Institution - 0111 | Vancouver | British Columbia |
| China | Local Institution - 0158 | Baotou | Neimeng |
| China | Local Institution - 0146 | Beijing | Beijing |
| China | Local Institution - 0152 | Beijing | Beijing |
| China | Local Institution - 0126 | Bengbu | Anhui |
| China | Local Institution - 0161 | Changsha | Hunan |
| China | Local Institution - 0170 | Changsha | Hunan |
| China | Local Institution - 0125 | Changzhou | Jiangsu |
| China | Local Institution - 0164 | Chengdu | Sichuan |
| China | Local Institution - 0135 | Guangzhou | Guangdong |
| China | Local Institution - 0153 | Guangzhou | Guangdong |
| China | Local Institution - 0157 | Hohhot | Neimeng |
| China | Local Institution - 0148 | Jiujiang | Jiangxi |
| China | Local Institution - 0134 | Kunming | Yunnan |
| China | Local Institution - 0131 | Nanchang | Jiangxi |
| China | Local Institution - 0156 | Nanchang | Jiangxi |
| China | Local Institution - 0138 | Nanjing | Jiangsu |
| China | Local Institution - 0139 | Nantong | Jiangsu |
| China | Local Institution - 0140 | Pingxiang | Jiangxi |
| China | Local Institution - 0207 | Shanghai | Shanghai |
| China | Local Institution - 0191 | Shenyang | Liaoning |
| China | Local Institution - 0206 | Shenzhen | Guangdong |
| China | Local Institution - 0117 | Urumqi | Xinjiang |
| China | Local Institution - 0129 | Wenzhou | Zhejiang |
| China | Local Institution - 0163 | Wuxi | Jiangsu |
| China | Local Institution - 0154 | Xi'An | Shan3xi |
| China | Local Institution - 0127 | Zhengzhou | Henan |
| Colombia | Local Institution - 0072 | Barranquilla | Atlántico |
| Colombia | Local Institution - 0015 | Bogotá | |
| Colombia | Local Institution - 0020 | Cali | Valle Del Cauca |
| Colombia | Local Institution - 0022 | Chía | |
| Colombia | Local Institution - 0019 | Medellin | |
| Czechia | Local Institution - 0010 | Brno | |
| Czechia | Local Institution - 0009 | Ostrava | |
| Czechia | Local Institution - 0035 | Ostrava | |
| Czechia | Local Institution - 0011 | Praha 2 | |
| Czechia | Local Institution - 0023 | Uherske Hradiste | |
| Germany | Local Institution - 0100 | Düsseldorf | |
| Germany | Local Institution - 0199 | Erlangen | |
| Germany | Local Institution - 0046 | Hamburg | |
| Germany | Local Institution - 0101 | Köln | |
| Germany | Local Institution - 0075 | Magdeburg | |
| Germany | Local Institution - 0201 | Minden | |
| Germany | Local Institution - 0176 | Ratingen | Nordrhein-Westfalen |
| Germany | Local Institution - 0074 | Tübingen | |
| Hungary | Local Institution - 0197 | Budapest | |
| Hungary | Local Institution - 0066 | Debrecen | |
| Hungary | Local Institution - 0028 | Gyula | |
| Hungary | Local Institution - 0027 | Kistarcsa | |
| Hungary | Local Institution - 0024 | Szarvas | |
| Hungary | Local Institution - 0025 | Veszprem | |
| Italy | Azienda Ospedaliera Universitaria Careggi-Reumatologia | Firenze | |
| Italy | AOR San Carlo di Potenza-UOC Reumatologia | Potenza | |
| Italy | Local Institution - 0097 | Roma | |
| Japan | Local Institution - 0205 | Bunkyo | Tokyo |
| Japan | Local Institution - 0121 | Chuo-ku | Tokyo |
| Japan | Local Institution - 0155 | Fukuoka | |
| Japan | Local Institution - 0067 | Itabashi-ku | Tokyo |
| Japan | Local Institution - 0123 | Kawachinagano | Osaka |
| Japan | Local Institution - 0178 | Meguro-ku | Tokyo |
| Japan | Local Institution - 0122 | Minato-ku | Tokyo |
| Japan | Local Institution - 0174 | Mitaka | Tokyo |
| Japan | Local Institution - 0202 | Nagoya | Aichi |
| Japan | Local Institution - 0106 | Nagoya-shi | Aichi |
| Japan | Local Institution - 0166 | Osaka | |
| Japan | Local Institution - 0204 | Osaka | |
| Japan | Local Institution - 0151 | Sapporo | Hokkaido |
| Japan | Local Institution - 0065 | Shinjuku-ku | Tokyo |
| Japan | Local Institution - 0179 | Tsu | MIE |
| Mexico | Local Institution - 0053 | Chihuahua | |
| Mexico | Local Institution - 0051 | Guadalajara | Jalisco |
| Mexico | Local Institution - 0052 | Leon | Guanajuato |
| Mexico | Local Institution - 0056 | Merida | Yucatan |
| Mexico | Local Institution - 0198 | Mexico City | Distrito Federal |
| Mexico | Local Institution - 0057 | Zapopan | Jalisco |
| Poland | Local Institution - 0082 | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Local Institution - 0080 | Elblag | |
| Poland | Local Institution - 0079 | Gdansk | Pomorskie |
| Poland | Local Institution - 0081 | Torun | |
| Poland | Local Institution - 0177 | Warszawa | Mazowieckie |
| Poland | Local Institution - 0112 | Wroclaw | |
| Russian Federation | Local Institution | Moscow | |
| Russian Federation | Local Institution - 0145 | Saint Petersburg | |
| Russian Federation | Local Institution - 0208 | Saint Petersburg | Sankt-Peterburg |
| Spain | Local Institution - 0014 | Barcelona | |
| Spain | Local Institution - 0012 | Madrid | |
| Spain | Local Institution - 0045 | Santander | |
| Spain | Local Institution - 0013 | València | |
| Taiwan | Local Institution - 0088 | Taichung | |
| Taiwan | Local Institution - 0089 | Taichung | |
| Taiwan | Local Institution - 0090 | Taichung City | |
| Taiwan | Local Institution - 0087 | Taipei | |
| Taiwan | Local Institution - 0091 | Taipei | |
| United Kingdom | Local Institution - 0060 | Bradford | |
| United Kingdom | Local Institution - 0064 | Hull | |
| United Kingdom | Local Institution - 0077 | Liverpool | |
| United Kingdom | Local Institution - 0062 | London | |
| United Kingdom | Local Institution - 0185 | London | England |
| United Kingdom | Local Institution - 0105 | Manchester | |
| United States | Local Institution - 0195 | Baton Rouge | Louisiana |
| United States | Bay Area Arthritis and Osteoporosis | Brandon | Florida |
| United States | Local Institution - 0196 | Charlotte | North Carolina |
| United States | Local Institution - 0180 | Cleveland | Ohio |
| United States | Local Institution - 0169 | Cumberland | Maryland |
| United States | Local Institution - 0016 | Duncansville | Pennsylvania |
| United States | Local Institution - 0133 | Eagan | Minnesota |
| United States | First OC Dermatology-Dermatology | Fountain Valley | California |
| United States | Local Institution - 0190 | Franklin | Wisconsin |
| United States | Local Institution - 0109 | Hattiesburg | Mississippi |
| United States | Local Institution - 0203 | Hopkinsville | Kentucky |
| United States | Local Institution - 0034 | Lansing | Michigan |
| United States | Local Institution - 0167 | Lubbock | Texas |
| United States | Local Institution - 0070 | Mesquite | Texas |
| United States | Local Institution - 0175 | Milwaukee | Wisconsin |
| United States | Local Institution - 0149 | Mountain Brook | Alabama |
| United States | Local Institution - 0108 | New York | New York |
| United States | Local Institution - 0189 | Oklahoma City | Oklahoma |
| United States | Local Institution - 0184 | Plano | Texas |
| United States | Local Institution - 0147 | Portland | Oregon |
| United States | Local Institution - 0186 | Rochester | New York |
| United States | Local Institution - 0212 | Sacramento | California |
| United States | Local Institution - 0187 | Seattle | Washington |
| United States | University Of Washington | Seattle | Washington |
| United States | Local Institution - 0192 | Skokie | Illinois |
| United States | Local Institution - 0182 | Summerville | South Carolina |
| United States | Local Institution - 0188 | Whittier | California |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Belgium, Canada, China, Colombia, Czechia, Germany, Hungary, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) | At week 16 | ||
| Secondary | Change from baseline Disease Activity Score 28 with C-Reactive Protein (DAS28-CRP) | At week 16 | ||
| Secondary | Change from baseline Health Assessment Questionnaire - Disability Index (HAQ-DI) | At week 16 | ||
| Secondary | Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response | At week 16 | ||
| Secondary | Change from baseline 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 among the participants with dactylitis at baseline | 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 meeting PASI 75 response | Up to 16 weeks | ||
| Secondary | Proportion of participants meeting PASI 90 response | Up to 16 weeks | ||
| Secondary | Proportion of participants meeting 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 weeks | ||
| 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 | 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-5L) utility scores | Up to 16 weeks | ||
| Secondary | Change from baseline in the 5-level EQ-5D 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 week 156 | ||
| Secondary | Incidence of Serious Adverse Events (SAEs) | Up to week 156 |
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