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Rosnilimab

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |AnaptysBio, Inc.|Last Updated: Oct 3, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment420

FDA Designations

No designations recorded

Clinical trial landscape

Rosnilimab · 2 trials · 2 indications

Phase 2 2
NCT06127043A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)Ulcerative Colitis
ACTIVE NOT_RECRUITING132 Analytics
NCT06041269A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)Rheumatoid Arthritis
ACTIVE NOT_RECRUITING420 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)
Ulcerative ColitisUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change in modified Mayo Score (mMs) from Baseline to Week 12
Baseline to Week 12

The mMS is an endoscopic and clinical scale, which ranges in scores from 0-9, with higher numbers indicating increased disease severity. It is used to assess UC disease activity. It consists of three subscores: RBS, SFS and an endoscopy subscore.

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 Endpoints

Proportion of subjects achieving clinical remission at Week 12
Baseline to Week 12
Proportion of subjects showing endoscopic treatment improvement at Week 12
Baseline to Week 12
Proportion of subjects achieving a clinical response at Week 12
Baseline to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Rosnilimab SC Dose 1EXPERIMENTALThis arm will receive High dose Rosnilimab SC
Rosnilimab SC Dose 2EXPERIMENTALThis arm will receive low dose Rosnilimab SC
PlaceboPLACEBO_COMPARATORThis arm will receive Placebo SC
Rosnilimab SC Dose 3EXPERIMENTALThis arm will receive treatment SC

Interventions

NameTypeDescription
RosnilimabDRUGPD-1 agonist antibody
PlaceboDRUGAdministered via SC
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites100

Inclusion Criteria: * Male or female ≥18 * Participants with a clinical diagnosis of UC for prior to Day 1 * Subject has moderate to severe, active UC, defined as a mMS ≥ 5 with an endoscopy subscore ≥2 * Subject has had a surveillance colonoscopy that did not detect potential dysplasia or colon ca...

Countries:United StatesAustriaBulgariaCanadaCroatiaFranceGeorgiaGermanyItalyNetherlandsPolandRomaniaSerbiaSpainUnited KingdomBelgiumEstoniaHungaryMoldovaSlovakiaUkraine
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Frequently asked questions about Rosnilimab

What is Rosnilimab used for?

Rosnilimab is an investigational antibody being developed for moderate to severe rheumatoid arthritis and moderate to severe ulcerative colitis. It is currently in Phase 2 clinical trials for both indications.

How does Rosnilimab work?

Rosnilimab is a monoclonal antibody, indicated by its -mab suffix. It is being studied for its efficacy and safety in treating autoimmune conditions like rheumatoid arthritis and ulcerative colitis, though its specific molecular target is not disclosed in available information.

Who is developing Rosnilimab?

Rosnilimab is being developed by AnaptysBio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ANAB.

What phase is Rosnilimab in?

Rosnilimab is in Phase 2 clinical development. It is not approved by regulatory authorities and remains investigational, with active trials ongoing for rheumatoid arthritis and ulcerative colitis.

What clinical trials is Rosnilimab in?

Rosnilimab is being studied in two Phase 2 trials: NCT06041269, known as RENOIR, for moderate to severe rheumatoid arthritis with 420 participants, and NCT06127043, known as ROSETTA, for moderate to severe ulcerative colitis with 132 participants. Both are active but not recruiting.