Rheumatoid ArthritisPhase 2NCT06041269

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

A Phase 2 study testing Rosnilimab in people with Rheumatoid Arthritis, run by AnaptysBio, Inc. at 92 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Rosnilimab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 420 participants
Where: 92 sitesin 15 countries
Study dates: 31 Aug 2023to 30 May 2025
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

92 sites in 15 countries.

Country

City, postcode or hospital

92 sites in 15 countries

United States36 sites

AnaptysBio Investigative Site 10-116
Albuquerque, New Mexico, 87102
AnaptysBio Investigative Site 10-120
Allen, Texas, 75013
AnaptysBio Investigative Site 10-103
Aventura, Florida, 33180
AnaptysBio Investigative Site 10-141
Avon Park, Florida, 33825
AnaptysBio Investigative Site 10-117
Beckley, West Virginia, 25801
AnaptysBio Investigative Site 10-118
Boynton Beach, Florida, 33436
AnaptysBio Investigative Site 10-143
Brookline, Massachusetts, 02445
AnaptysBio Investigative Site 10-114
Chicago, Illinois, 60640
AnaptysBio Investigative Site 10-107
Colleyville, Texas, 76034
AnaptysBio Investigative Site 10-105
Covina, California, 91722
AnaptysBio Investigative Site 10-125
Daytona Beach, Florida, 32117
AnaptysBio Investigative Site 10-132
Flagstaff, Arizona, 86001
AnaptysBio Investigative Site 10-130
Glendale, Arizona, 85306
AnaptysBio Investigative Site 10-122
Homestead, Florida, 33032
AnaptysBio Investigative Site 10-101
Jackson, Tennessee, 38305
AnaptysBio Investigative Site 10-123
Katy, Texas, 77450
AnaptysBio Investigative Site 10-108
Mesquite, Texas, 75150
Anaptys Bio Investigative Site 10-142
Miami, Florida, 33125
AnaptysBio Investigative Site 10-140
Miami, Florida, 33126
AnaptysBio Investigative Site 10-102
Miami, Florida, 33155
AnaptysBio Investigative Site 10-146
Middleburg Heights, Ohio, 44130
AnaptysBio Investigative Site 10-145
Monroe, Louisiana, 71203
AnaptysBio Investigative Site 10-129
Phoenix, Arizona, 85037
AnaptysBio Investigative Site 10-110
Plano, Texas, 75024
AnaptysBio Investigative Site 10-124
Plantation, Florida, 33324
Anaptys Bio Investigative Site 10-119
Rancho Mirage, California, 92270
AnaptysBio Investigative Site 10-113
San Diego, California, 92108
AnaptysBio Investigative Site 10-127
San Francisco, California, 94123
AnaptysBio Investigative Site 10-148
Smithfield, North Carolina, 27577
AnaptysBio Investigative Site 10-136
Temecula, California, 92592
AnaptysBio Investigative Site 10-106
The Woodlands, Texas, 77382
AnaptysBio Investigative Site 10-121
Tomball, Texas, 77375
AnaptysBio Investigative Site 10-131
Tucson, Arizona, 85704
AnaptysBio Investigative Site 10-133
Upland, California, 91786
AnaptysBio Investigative Site 10-139
West Palm Beach, Florida, 33407
AnaptysBio Investigative Site 10-112
Whitter, California, 90602

Other trials in United States

Poland11 sites

AnaptysBio Investigative Site 30-111
Bialystok, 15-707
AnaptysBio Investigative Site 30-109
Bydgoszcz, 85-065
AnaptysBio Investigative Site 30-102
Bytom, Woj.Slaskie, 41-902
AnaptysBio Investigative Site 30-103
Nowa Sól, Lubusz Voivodeship, 67-100
AnaptysBio Investigative Site 30-106
Opole, Opole Voivodeship, 45-819
AnaptysBio Investigative Site 30-112
Poznan, Greater Poland Voivodeship, 60693
AnaptysBio Investigative Site 30-105
Poznan, Greater Poland Voivodeship, 61-113
AnaptysBio Investigative Site 30-101
Poznan, Greater Poland Voivodeship, 61-293
AnaptysBio Investigative Site 30-104
Torun, Kuj-pom, 87-100
AnaptysBio Investigative Site 30-107
Warsaw, Masovian Voivodeship, 02-118
AnaptysBio Investigative Site 30-108
Warsaw, 00-874

Other trials in Poland

Georgia6 sites

AnaptysBio Investigative Site 59-101
Tbilisi, 0112
AnaptysBio Investigative Site 59-105
Tbilisi, 0131
AnaptysBio Investigative Site 59-104
Tbilisi, 0159
AnaptysBio Investigative Site 59-106
Tbilisi, 0159
AnaptysBio Investigative Site 59-102
Tbilisi, 0160
AnaptysBio Investigative Site 59-103
Tbilisi, 0172

Other trials in Georgia

Italy6 sites

AnaptysBio Investigative Site 20-104
Bari, 70124
AnaptysBio Investigative Site 20-106
Milan, Lombardy, 20162
AnaptysBio Investigative Site 20-110
Milan, 20122
AnaptysBio Investigative Site 20-105
Novara, 28100
AnaptysBio Investigative Site 20-101
Pavia, PV, 27100
AnaptysBio Investigative Site 20-108
Roma, 128

Other trials in Italy

Spain5 sites

AnaptysBio Investigative Site 24-101
Bilbao, Bizkaia, 48013
AnaptysBio Investigative Site 24-105
Córdoba, 14004
AnaptysBio Investigative Site 24-102
Santiago de Compostela, Coruna, 15895
AnaptysBio Investigative Site 24-104
Santiago de Compostela, 15702
AnaptysBio Investigative Site 24-103
Santiago de Compostela, 15706

Other trials in Spain

Belgium4 sites

AnaptysBio Investigative Site 13-102
Anderlecht, Brussels Capital, 1070
AnaptysBio Investigative Site 13-103
Antwerp, 2170
AnaptysBio Investigative Site 13-104
Leuven, Vlaams-Braba, 3000
AnaptysBio Investigative Site 13- 105
Liège, Liège, 4000

Other trials in Belgium

Germany4 sites

AnaptysBio Investigative Site 17-103
Berlin, 12161
AnaptysBio Investigative Site 17-102
Hamburg, 20095
AnaptysBio Investigative Site 17-107
Hanover, 30159
AnaptysBio Investigative Site 17-105
Herne, 44649

Other trials in Germany

Hungary4 sites

AnaptysBio Investigative Site 28-104
Budapest, Budapest, 1036
AnaptysBio Investigative Site 28-101
Budapest, Pest County, 1023
Anaptys Bio Investigative Site 28-106
Budapest, 1036
AnaptysBio Investigative Site 28-103
Debrecen, Hajdú-Bihar, 4032

Other trials in Hungary

Canada3 sites

AnaptysBio Investigative Site 11-104
Niagara Falls, Ontario, L2E6A6
AnaptysBio Investigative Site 11-103
Trois-Rivières, Quebec, G9A 3Y2
AnaptysBio Investigative Site 11-101
Windsor, Ontario, N8X1T3

Other trials in Canada

Estonia3 sites

AnaptysBio Investigative Site 71-102
Tallinn, Estonia, 10117
AnaptysBio Investigative Site 71-101
Tallinn, Estonia, 13419
AnaptysBio Investigative Site 71-103
Tartu, Tartu, 50106

Other trials in Estonia

France3 sites

AnaptysBio Investigative Site 16-105
Cahors, 46000
AnaptysBio Investigative Site 16-101
Montpellier, 34090
AnaptysBio Investigative Site 16-102
Toulouse, 31059

Other trials in France

Slovakia3 sites

AnaptysBio Investigative Site 67-101
Košice, Slovakia, 4011
AnaptysBio Investigative Site 67-102
Martin, 03601
AnaptysBio Investigative Site 67-103
Piešťany, 92101

Other trials in Slovakia

United Kingdom2 sites

AnaptysBio Investigative Site 27-101
London, IG14HP
AnaptysBio Investigative Site 27-102
Manchester, M278FF

Other trials in United Kingdom

Moldova1 site

AnaptysBio Investigative Site73-101
Chisinau, Kishinev, MD-2025

Other trials in Moldova

Ukraine1 site

AnaptysBio Investigative Site 34-101
Kyiv, 01135

Other trials in Ukraine

About this study

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

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

Read the 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.

Conditions: Rheumatoid Arthritis
Being tested: Rosnilimab, Placebo
Keywords: PD-1 Agonist, ANB030, RENOIR, Rosnilimab
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RosnilimabDrug
Also called ANB030
PD-1 agonist antibody
PlaceboDrug
Placebo

Study groups in NCT06041269
Study group	Role	What they receive
Rosnilimab SC Dose 1	Experimental	This arm will receive treatment SC Receives: Drug: Rosnilimab
Rosnilimab SC Dose 2	Experimental	This arm will receive treatment SC Receives: Drug: Rosnilimab
Rosnilimab SC Dose 3	Experimental	This arm will receive treatment SC Receives: Drug: Rosnilimab
Placebo	Placebo comparator	This arm will receive Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at 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
Measured: Baseline to Week 12

Secondary outcomes (2)

American College of Rheumatology 20% Improvement Criteria (ACR20) response rate at Week 12
Measured: Baseline to Week 12
American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12
Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 202330 May 2025

First posted18 Sep 2023
Study start31 Aug 2023
Primary completion29 Nov 2024 (estimated)
Study completion30 May 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 420 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06041269
Sponsor's protocol ID: ANB030-203
Status last verified: Nov 2024
First submitted: 11 Sep 2023
Last updated: 25 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06041269
Acronym / sponsor ID: ANB030-203
Conditions: Rheumatoid Arthritis
Keywords: PD-1 Agonist, ANB030, RENOIR, Rosnilimab
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 420 participants (estimated)
Lead sponsor: AnaptysBio, Inc.Industry (pharma, biotech, devices)
Study start: 31 Aug 2023 (actual)
Primary completion: 29 Nov 2024 (estimated)
Study completion: 30 May 2025 (estimated)
First posted: 18 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Rosnilimab SC Dose 1	Experimental	Drug: RosnilimabThis arm will receive treatment SC
Rosnilimab SC Dose 2	Experimental	Drug: RosnilimabThis arm will receive treatment SC
Rosnilimab SC Dose 3	Experimental	Drug: RosnilimabThis arm will receive treatment SC
Placebo	Placebo comparator	Drug: PlaceboThis arm will receive Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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 (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RosnilimabAlso: ANB030PD-1 agonist antibody	Drug	Rosnilimab SC Dose 1, Rosnilimab SC Dose 2, Rosnilimab SC Dose 3
PlaceboPlacebo	Drug	Placebo

Primary outcome

Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12
Time frame: 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

2 secondary outcomes

American College of Rheumatology 20% Improvement Criteria (ACR20) response rate at Week 12
Time frame: Baseline to Week 12
American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12
Time frame: Baseline to Week 12

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
Individual participant dataSharing planned: Yes

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

92 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rosnilimab in people with Rheumatoid Arthritis, run by AnaptysBio, Inc. at 92 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Poland, Georgia, Italy, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06041269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.