A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)

AnaptysBio

Status and phase: Active, not recruiting; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Rosnilimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06041269

ANB030-203

Details and patient eligibility

About

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

Full 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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420 participants in 4 patient groups, including a placebo group

Rosnilimab SC Dose 1

Experimental group

Description:

This arm will receive treatment SC

Treatment:

Drug: Rosnilimab

Rosnilimab SC Dose 2

Experimental group

Description:

This arm will receive treatment SC

Treatment:

Drug: Rosnilimab

Rosnilimab SC Dose 3

Experimental group

Description:

This arm will receive treatment SC

Treatment:

Drug: Rosnilimab

Placebo

Placebo Comparator group

Description:

This arm will receive Placebo

Treatment:

Drug: Placebo