Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Rheumatoid Arthritis (Renoir)
Study Details
Study Description
Brief Summary
Renoir Study: This study will evaluate the safety, tolerability, and efficacy of ANB 030 in subjects with moderate to severe Rheumatoid Arthritis (RA)
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
This study is a Phase 2 global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab as an add on therapy in Subjects with Moderate to Severe Rheumatoid Arthritis.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: ANB030 SC Dose 1 This arm will receive treatment SC |
Drug: ANB030
PD-1 agonist antibody
Other Names:
|
Experimental: ANB030 SC Dose 2 This arm will receive treatment SC |
Drug: ANB030
PD-1 agonist antibody
Other Names:
|
Experimental: ANB030 SC Dose 3 This arm will receive treatment SC |
Drug: ANB030
PD-1 agonist antibody
Other Names:
|
Placebo Comparator: Placebo This arm will receive Placebo |
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12 [Baseline to 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
Secondary Outcome Measures
- American College of Rheumatology 20%, Improvement Criteria (ACR20) response rate at Week 12 [Baseline to Week 12]
- American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12 [Baseline to Week 12]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Aged 18 years or older.
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A diagnosis of Rheumatoid Arthritis based on ACR/EULAR 2010 classification criteria, for at least 3 months before participating in the trial.
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Must be receiving treatment with at least 1, but not more than 2 csDMARDs for at least 3 months and be on stage dosages for at least 8 weeks prior to joining and throughout the trial
Key Exclusion Criteria:
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History of an inflammatory joint disease other than Rheumatoid Arthritis
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Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator
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History of cancer within the last 5 years (except for some skin cancers)
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Any known or suspected condition that would compromise immune status.
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Pregnant or breastfeeding women.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | AnaptysBio Investigative Site 10-112 | Whittier | California | United States | 90602 |
2 | AnaptysBio Investigative Site 10-103 | Aventura | Florida | United States | 33180 |
3 | AnaptysBio Investigative Site 10-122 | Homestead | Florida | United States | 33032 |
4 | AnaptysBio Investigative Site 10-102 | Miami | Florida | United States | 33155 |
5 | AnaptysBio Investigative Site 10-124 | Plantation | Florida | United States | 33324 |
6 | AnaptysBio Investigative Site 10-101 | Jackson | Tennessee | United States | 38305 |
7 | AnaptysBio Investigative Site 10-108 | Mesquite | Texas | United States | 75150 |
8 | AnaptysBio Investigative Site 47-101 | Mar del Plata | Beunos Aires | Argentina | 7600 |
9 | AnaptysBio Investigative Site 47-104 | Zárate | Beunos Aires | Argentina | 2800 |
10 | AnaptysBio Investigative Site 47-102 | Rosario | Santa Fe | Argentina | 2000 |
11 | AnaptysBio Investigative Site 47-105 | Rosario | Santa Fe | Argentina | 2000 |
12 | AnaptysBio Investigative Site 47-103 | San Miguel De Tucumán | Tucuman | Argentina | 4000 |
13 | AnaptysBio Investigative Site 47-105 | Cordoba | Argentina | 5016 | |
14 | AnaptysBio Investigative Site 71-101 | Tallinn | Estonia | 13419 | |
15 | AnaptysBio Investigative Site 59-101 | Tbilisi | Georgia | 0112 | |
16 | AnaptysBio Investigative Site 59-105 | Tbilisi | Georgia | 0131 | |
17 | AnaptysBio Investigative Site 59-104 | Tbilisi | Georgia | 0159 | |
18 | AnaptysBio Investigative Site 59-106 | Tbilisi | Georgia | 0159 | |
19 | AnaptysBio Investigative Site 59-102 | Tbilisi | Georgia | 0160 | |
20 | AnaptysBio Investigative Site 59-103 | Tbilisi | Georgia | 0172 | |
21 | AnaptysBio Investigative Site 28-103 | Debrecen | Hajdu-Bihar | Hungary | 4032 |
22 | AnaptysBio Investigative Site 28-104 | Budapest | Hungary | 1036 | |
23 | AnaptysBio Investigative Site 51-102 | San Miguel | Ciudad De Mexico | Mexico | 11850 |
24 | AnaptysBio Investigative Site 51-106 | Mexico City | Mexico | 11650 | |
25 | AnaptysBio Investigative Site 73-101 | Chisinau | Kishinev | Moldova, Republic of | 29 |
26 | AnaptysBio Investigative Site 72-103 | Cayma | Arequipa | Peru | 4001 |
27 | AnaptysBio Investigative Site 72-103 | Bella Vista | Callao | Peru | Callao 2 |
28 | AnaptysBio Investigative Site 72-102 | San Isidro | Lima | Peru | Lima 27 |
29 | AnaptysBio Investigative Site 30-107 | Warsaw | Mazowieckie | Poland | 02-118 |
30 | AnaptysBio Investigative Site 30-112 | Poznań | Wielkopolskie | Poland | 60693 |
31 | AnaptysBio Investigative Site 30-102 | Bytom | Woj.Slaskie | Poland | 41-902 |
32 | AnaptysBio Investigative Site 67-101 | Košice | Slovakia | 4011 |
Sponsors and Collaborators
- AnaptysBio, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ANB030-203