Clinical trial NCT06041269: A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: PD-1 Agonist
ANB030
RENOIR
Rosnilimab
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-18
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)

Detailed description: This study is a Phase 2 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: American College of Rheumatology 20% Improvement Criteria (ACR20) response rate at Week 12
timeFrame: Baseline to Week 12
measure: American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: AnaptysBio Investigative Site 10-132
state: Arizona
city: Glendale
country: United States
facility: AnaptysBio Investigative Site 10-130
state: Arizona
city: Phoenix
country: United States
facility: AnaptysBio Investigative Site 10-129
state: Arizona
city: Tucson
country: United States
facility: AnaptysBio Investigative Site 10-131
state: Arizona
city: Covina
country: United States
facility: AnaptysBio Investigative Site 10-105
state: California
city: Rancho Mirage
country: United States
facility: Anaptys Bio Investigative Site 10-119
state: California
city: San Diego
country: United States
facility: AnaptysBio Investigative Site 10-113
state: California
city: San Francisco
country: United States
facility: AnaptysBio Investigative Site 10-127
state: California
city: Temecula
country: United States
facility: AnaptysBio Investigative Site 10-136
state: California
city: Upland
country: United States
facility: AnaptysBio Investigative Site 10-133
state: California
city: Whitter
country: United States
facility: AnaptysBio Investigative Site 10-112
state: California
city: Aventura
country: United States
facility: AnaptysBio Investigative Site 10-103
state: Florida
city: Avon Park
country: United States
facility: AnaptysBio Investigative Site 10-141
state: Florida
city: Boynton Beach
country: United States
facility: AnaptysBio Investigative Site 10-118
state: Florida
city: Daytona Beach
country: United States
facility: AnaptysBio Investigative Site 10-125
state: Florida
city: Homestead
country: United States
facility: AnaptysBio Investigative Site 10-122
state: Florida
city: Miami
country: United States
facility: Anaptys Bio Investigative Site 10-142
state: Florida
city: Miami
country: United States
facility: AnaptysBio Investigative Site 10-140
state: Florida
city: Miami
country: United States
facility: AnaptysBio Investigative Site 10-102
state: Florida
city: Plantation
country: United States
facility: AnaptysBio Investigative Site 10-124
state: Florida
city: West Palm Beach
country: United States
facility: AnaptysBio Investigative Site 10-139
state: Florida
city: Chicago
country: United States
facility: AnaptysBio Investigative Site 10-114
state: Illinois
city: Monroe
country: United States
facility: AnaptysBio Investigative Site 10-145
state: Louisiana
city: Brookline
country: United States
facility: AnaptysBio Investigative Site 10-143
state: Massachusetts
city: Albuquerque
country: United States
facility: AnaptysBio Investigative Site 10-116
state: New Mexico
city: Smithfield
country: United States
facility: AnaptysBio Investigative Site 10-148
state: North Carolina
city: Middleburg Heights
country: United States
facility: AnaptysBio Investigative Site 10-146
state: Ohio
city: Jackson
country: United States
facility: AnaptysBio Investigative Site 10-101
state: Tennessee
city: Allen
country: United States
facility: AnaptysBio Investigative Site 10-120
state: Texas
city: Colleyville
country: United States
facility: AnaptysBio Investigative Site 10-107
state: Texas
city: Katy
country: United States
facility: AnaptysBio Investigative Site 10-123
state: Texas
city: Mesquite
country: United States
facility: AnaptysBio Investigative Site 10-108
state: Texas
city: Plano
country: United States
facility: AnaptysBio Investigative Site 10-110
state: Texas
city: The Woodlands
country: United States
facility: AnaptysBio Investigative Site 10-106
state: Texas
city: Tomball
country: United States
facility: AnaptysBio Investigative Site 10-121
state: Texas
city: Beckley
country: United States
facility: AnaptysBio Investigative Site 10-117
state: West Virginia
city: Anderlecht
country: Belgium
facility: AnaptysBio Investigative Site 13-102
state: Bruxelles
city: Leuven
country: Belgium
facility: AnaptysBio Investigative Site 13-104
state: Vlaams-Braba
city: Antwerp
country: Belgium
facility: AnaptysBio Investigative Site 13-103
city: Liège
country: Belgium
facility: AnaptysBio Investigative Site 13- 105
city: Niagara Falls
country: Canada
facility: AnaptysBio Investigative Site 11-104
state: Ontario
city: Windsor
country: Canada
facility: AnaptysBio Investigative Site 11-101
state: Ontario
city: Trois-Rivières
country: Canada
facility: AnaptysBio Investigative Site 11-103
state: Quebec
city: Tartu
country: Estonia
facility: AnaptysBio Investigative Site 71-103
state: Tartumaa
city: Tallinn
country: Estonia
facility: AnaptysBio Investigative Site 71-102
city: Tallinn
country: Estonia
facility: AnaptysBio Investigative Site 71-101
city: Cahors
country: France
facility: AnaptysBio Investigative Site 16-105
city: Montpellier
country: France
facility: AnaptysBio Investigative Site 16-101
city: Toulouse cedex 9
country: France
facility: AnaptysBio Investigative Site 16-102
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-101
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-105
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-104
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-106
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-102
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigative Site 59-103
city: Berlin
country: Germany
facility: AnaptysBio Investigative Site 17-103
city: Hamburg
country: Germany
facility: AnaptysBio Investigative Site 17-102
city: Hanover
country: Germany
facility: AnaptysBio Investigative Site 17-107
city: Herne
country: Germany
facility: AnaptysBio Investigative Site 17-105
city: Debrecen
country: Hungary
facility: AnaptysBio Investigative Site 28-103
state: Hajdu-Bihar
city: Budapest
country: Hungary
facility: AnaptysBio Investigative Site 28-101
state: Pest
city: Budapest
country: Hungary
facility: Anaptys Bio Investigative Site 28-106
city: Budapest
country: Hungary
facility: AnaptysBio Investigative Site 28-104
city: Milan
country: Italy
facility: AnaptysBio Investigative Site 20-106
state: Lombardy
city: Pavia
country: Italy
facility: AnaptysBio Investigative Site 20-101
state: PV
city: Bari
country: Italy
facility: AnaptysBio Investigative Site 20-104
city: Milan
country: Italy
facility: AnaptysBio Investigative Site 20-110
city: Novara
country: Italy
facility: AnaptysBio Investigative Site 20-105
city: Roma
country: Italy
facility: AnaptysBio Investigative Site 20-108
city: Chisinau
country: Moldova, Republic of
facility: AnaptysBio Investigative Site73-101
state: Kishinev
city: Toruń
country: Poland
facility: AnaptysBio Investigative Site 30-104
state: Kuj-pom
city: Nowa Sól
country: Poland
facility: AnaptysBio Investigative Site 30-103
state: Lubuskie
city: Warsaw
country: Poland
facility: AnaptysBio Investigative Site 30-107
state: Mazowieckie
city: Opole
country: Poland
facility: AnaptysBio Investigative Site 30-106
state: Opolskie
city: Poznań
country: Poland
facility: AnaptysBio Investigative Site 30-112
state: Wielkopolskie
city: Poznań
country: Poland
facility: AnaptysBio Investigative Site 30-105
state: Wielkopolskie
city: Poznań
country: Poland
facility: AnaptysBio Investigative Site 30-101
state: Wielkopolskie
city: Bytom
country: Poland
facility: AnaptysBio Investigative Site 30-102
state: Woj.Slaskie
city: Białystok
country: Poland
facility: AnaptysBio Investigative Site 30-111
city: Bydgoszcz
country: Poland
facility: AnaptysBio Investigative Site 30-109
city: Warsaw
country: Poland
facility: AnaptysBio Investigative Site 30-108
city: Košice
country: Slovakia
facility: AnaptysBio Investigative Site 67-101
city: Martin
country: Slovakia
facility: AnaptysBio Investigative Site 67-102
city: Piešťany
country: Slovakia
facility: AnaptysBio Investigative Site 67-103
city: Bilbao
country: Spain
facility: AnaptysBio Investigative Site 24-101
state: Bizkaia
city: Santiago de Compostela
country: Spain
facility: AnaptysBio Investigative Site 24-102
state: Coruna
city: Córdoba
country: Spain
facility: AnaptysBio Investigative Site 24-105
city: Santiago De Compostela
country: Spain
facility: AnaptysBio Investigative Site 24-104
city: Santiago De Compostela
country: Spain
facility: AnaptysBio Investigative Site 24-103
city: Kyiv
country: Ukraine
facility: AnaptysBio Investigative Site 34-101
city: London
country: United Kingdom
facility: AnaptysBio Investigative Site 27-101
city: Manchester
country: United Kingdom
facility: AnaptysBio Investigative Site 27-102
Study officials:
References: