Rheumatoid Arthritis Clinical Trial
Official title:
A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Rheumatoid Arthritis
RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)
| Status | Recruiting |
| Enrollment | 420 |
| Est. completion date | October 8, 2025 |
| Est. primary completion date | March 8, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Key Inclusion Criteria: - Aged 18 years or older - A diagnosis of Rheumatoid Arthritis based on ACR/EULAR 2010 classification criteria, for at least 3 months before participating in the trial - Must be receiving treatment with at least 1, but not more than 2 csDMARDs for at least 3 months and be on stable dosages for at least 8 weeks prior to joining and throughout the trial - Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD (bDMARD), or targeted synthetic DMARD (tsDMARD) treatment Key Exclusion Criteria: - History of an inflammatory joint disease other than Rheumatoid Arthritis - Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator - History of cancer within the last 5 years (except for some skin cancers) - Any known or suspected condition that would compromise immune status - Pregnant or breastfeeding women |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | AnaptysBio Investigative Site 47-105 | Cordoba | |
| Argentina | AnaptysBio Investigative Site 47-101 | Mar del Plata | Beunos Aires |
| Argentina | AnaptysBio Investigative Site 47-102 | Rosario | Santa Fe |
| Argentina | AnaptysBio Investigative Site 47-105 | Rosario | Santa Fe |
| Argentina | AnaptysBio Investigative Site 47-103 | San Miguel De Tucumán | Tucuman |
| Argentina | AnaptysBio Investigative Site 47-104 | Zárate | Beunos Aires |
| Belgium | Anaptys Bio Investigative Site 13-102 | Anderlecht | Bruxelles |
| Belgium | Anaptys Bio Investigative Site 13-103 | Antwerp | |
| Belgium | Anaptys Bio Investigative Site 13-101 | Bruxelles | |
| Belgium | Anaptys Bio Investigative Site 13-104 | Leuven | Vlaams-Braba |
| Belgium | Anaptys Bio Investigative Site 13- 105 | Liège | |
| Canada | Anaptys Bio Investigative Site 11-102 | Hamilton | Ontario |
| Canada | Anaptys Bio Investigative Site 11-104 | Niagara Falls | Ontario |
| Canada | Anaptys Bio Investigative Site 11-103 | Trois-Rivières | Quebec |
| Canada | Anaptys Bio Investigative Site 11-101 | Windsor | Ontario |
| Estonia | Anaptys Bio Investigative Site 71-102 | Tallinn | |
| Estonia | AnaptysBio Investigative Site 71-101 | Tallinn | |
| Estonia | Anaptys Bio Investigative Site 71-103 | Tartu | Tartumaa |
| Georgia | AnaptysBio Investigative Site 59-101 | Tbilisi | |
| Georgia | AnaptysBio Investigative Site 59-102 | Tbilisi | |
| Georgia | AnaptysBio Investigative Site 59-103 | Tbilisi | |
| Georgia | AnaptysBio Investigative Site 59-104 | Tbilisi | |
| Georgia | AnaptysBio Investigative Site 59-105 | Tbilisi | |
| Georgia | AnaptysBio Investigative Site 59-106 | Tbilisi | |
| Germany | Anaptys Bio Investigative Site 10-122 | Hamburg | |
| Hungary | Anaptys Bio Investigative Site 28-106 | Budapest | |
| Hungary | AnaptysBio Investigative Site 28-101 | Budapest | Pest |
| Hungary | AnaptysBio Investigative Site 28-104 | Budapest | |
| Hungary | AnaptysBio Investigative Site 28-102 | Debrecen | Hajdu-Bihar |
| Hungary | AnaptysBio Investigative Site 28-103 | Debrecen | Hajdu-Bihar |
| Italy | AnaptysBio Investigative Site 20-103 | Firenze | |
| Italy | AnaptysBio Investigative Site 20-101 | Pavia | PV |
| Italy | AnaptysBio Investigative Site 20-102 | Roma | |
| Mexico | AnaptysBio Investigational Site 51-104 | Guadalajara | Jalisco |
| Mexico | AnaptysBio Investigational Site 51-107 | Mexico City | |
| Mexico | AnaptysBio Investigative Site 51-106 | Mexico City | |
| Mexico | AnaptysBio Investigational Site 51-105 | Oaxaca | |
| Mexico | AnaptysBio Investigative Site 51-102 | San Miguel | Ciudad De Mexico |
| Moldova, Republic of | AnaptysBio Investigative Site 73-101 | Chisinau | Kishinev |
| Peru | AnaptysBio Investigative Site 72-104 | Bella Vista | Callao |
| Peru | AnaptysBio Investigative Site 72-103 | Cayma | Arequipa |
| Peru | AnaptysBio Investigative Site 72-102 | San Isidro | Lima |
| Poland | AnaptysBio Investigative Site 30-111 | Bialystok | |
| Poland | AnaptysBio Investigative Site 30-109 | Bydgoszcz | |
| Poland | AnaptysBio Investigative Site 30-102 | Bytom | Woj.Slaskie |
| Poland | AnaptysBio Investigative Site 30-103 | Nowa Sól | Lubuskie |
| Poland | AnaptysBio Investigative Site 30-106 | Opole | Opolskie |
| Poland | AnaptysBio Investigative Site 30-101 | Poznan | Wielkopolskie |
| Poland | AnaptysBio Investigative Site 30-105 | Poznan | Wielkopolskie |
| Poland | AnaptysBio Investigative Site 30-112 | Poznan | Wielkopolskie |
| Poland | AnaptysBio Investigative Site 30-104 | Torun | Kuj-pom |
| Poland | AnaptysBio Investigative Site 30-107 | Warsaw | Mazowieckie |
| Poland | AnaptysBio Investigative Site 30-108 | Warsaw | |
| Slovakia | AnaptysBio Investigative Site 67-101 | Košice | |
| Spain | AnaptysBio Investigative Site 24-101 | Bilbao | Bizkaia |
| Spain | AnaptysBio Investigative Site 24-105 | Córdoba | |
| Spain | AnaptysBio Investigative Site 24-102 | Santiago de Compostela | Coruna |
| Spain | AnaptysBio Investigative Site 24-103 | Santiago De Compostela | |
| Spain | AnaptysBio Investigative Site 24-104 | Santiago De Compostela | |
| United States | Anaptys Bio Investigative Site 10-116 | Albuquerque | New Mexico |
| United States | Anaptys Bio Investigative Site 10-120 | Allen | Texas |
| United States | AnaptysBio Investigative Site 10-103 | Aventura | Florida |
| United States | Anaptys Bio Investigative Site 10-117 | Beckley | West Virginia |
| United States | Anaptys Bio Investigative Site 10-118 | Boynton Beach | Florida |
| United States | Anaptys Bio Investigative Site 10-115 | Brandon | Florida |
| United States | Anaptys Bio Investigative Site 10-114 | Chicago | Illinois |
| United States | Anaptys Bio Investigative Site 10-107 | Colleyville | Texas |
| United States | Anaptys Bio Investigative Site 10-105 | Covina | California |
| United States | Anaptys Bio Investigative Site 10-125 | Daytona Beach | Florida |
| United States | Anaptys Bio Investigative Site 10-132 | Flagstaff | Arizona |
| United States | Anaptys Bio Investigative Site 10-126 | Fullerton | California |
| United States | Anaptys Bio Investigative Site 10-130 | Glendale | Arizona |
| United States | Anaptys Bio Investigative Site 10-134 | Grand Blanc | Michigan |
| United States | AnaptysBio Investigative Site 10-122 | Homestead | Florida |
| United States | AnaptysBio Investigative Site 10-101 | Jackson | Tennessee |
| United States | Anaptys Bio Investigative Site 10-123 | Katy | Texas |
| United States | AnaptysBio Investigative Site 10-108 | Mesquite | Texas |
| United States | AnaptysBio Investigative Site 10-102 | Miami | Florida |
| United States | Anaptys Bio Investigative Site 10-129 | Phoenix | Arizona |
| United States | Anaptys Bio Investigative Site 10-110 | Plano | Texas |
| United States | AnaptysBio Investigative Site 10-124 | Plantation | Florida |
| United States | Anaptys Bio Investigative Site 10-119 | Rancho Mirage | California |
| United States | Anaptys Bio Investigative Site 10-113 | San Diego | California |
| United States | Anaptys Bio Investigative Site 10-127 | San Francisco | California |
| United States | Anaptys Bio Investigative Site 10-106 | The Woodlands | Texas |
| United States | Anaptys Bio Investigative Site 10-121 | Tomball | Texas |
| United States | Anaptys Bio Investigative Site 10-131 | Tucson | Arizona |
| United States | Anaptys Bio Investigative Site 10-133 | Upland | California |
| United States | AnaptysBio Investigative Site 10-112 | Whittier | California |
| Lead Sponsor | Collaborator |
|---|---|
| AnaptysBio, Inc. |
United States, Argentina, Belgium, Canada, Estonia, Georgia, Germany, Hungary, Italy, Mexico, Moldova, Republic of, Peru, Poland, Slovakia, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12 | The DAS28-CRP is a validated composite assessment that assesses RA disease activity based on tender and swollen joint counts of 28 joints | Baseline to Week 12 | |
| Secondary | American College of Rheumatology 20% Improvement Criteria (ACR20) response rate at Week 12 | Baseline to Week 12 | ||
| Secondary | American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12 | Baseline to Week 12 |
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