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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06041269
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	AnaptysBio, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Belgium, Canada, Estonia, Georgia, Germany, Hungary, Italy, Mexico, Moldova, Republic of, Peru, Poland, Slovakia, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Rosnilimab SC Dose 1

This arm will receive treatment SC

Experimental: Rosnilimab SC Dose 2

This arm will receive treatment SC

Experimental: Rosnilimab SC Dose 3

This arm will receive treatment SC

Placebo Comparator: Placebo

This arm will receive Placebo

Interventions

Drug: - Rosnilimab

PD-1 agonist antibody

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Anaptys Bio Investigative Site 10-132, Flagstaff, Arizona

Status

Not yet recruiting

Address

Anaptys Bio Investigative Site 10-132

Flagstaff, Arizona, 86001

Site Contact

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