NCT07620392

Brief Summary

The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors, and who were previously treated with Afimkibart.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline
84mo left

Started Jun 2026

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Jul 2033

First Submitted

Initial submission to the registry

May 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

June 3, 2026

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2033

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

7.1 years

First QC Date

May 27, 2026

Last Update Submit

July 23, 2026

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Adverse Events (AEs)

    From Baseline up to 6 years

Secondary Outcomes (13)

  • Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)

    Up to 6 years

  • Change from baseline in Individual Components of ACR

    Baseline, Up to 6 years

  • Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With C-Reactive Protein (DAS28-CRP)

    Baseline, Up to 6 years

  • Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28-CRP Score

    Up to 6 years

  • Percentage of Participants LDA Achieving Based on Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation (DAS28-ESR) Score

    Up to 6 years

  • +8 more secondary outcomes

Study Arms (2)

Afimkibart Group I

EXPERIMENTAL

Participants will recieve Afimkibart as subcutaneous (SC) injection.

Drug: Afimkibart

Afimkibart Group II

EXPERIMENTAL

Participants will receive Afimkibart as SC injection.

Drug: Afimkibart

Interventions

AfimkibartDRUG

Participants will receive Afimkibart as per the schedule mentioned in the protocol.

Also known as: PF-06480605, RVT-3101, RO7790121
Afimkibart Group IAfimkibart Group II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completed the treatment period of the parent study
  • Agreement to adhere to the contraception requirements
  • Continued to be evaluated at the follow-up visit of the parent study and achieved improvement in the SJC66/TJC68 relative to baseline

You may not qualify if:

  • Withdrawal of consent and/or premature discontinuation from parent study
  • Any permanent discontinuation of study drug in parent study
  • Use of a prohibited therapy during the parent study
  • Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude participant participation in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

West Broward Rheumatology Associates, Inc.

Tamarac, Florida, 33321, United States

RECRUITING

Accurate Clinical Management LLC

Houston, Texas, 77089, United States

RECRUITING

DM Clinical Research

Tomball, Texas, 77375, United States

RECRUITING

Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne

Elblag, 82-300, Poland

RECRUITING

Zespol Poradni Specjalistycznych REUMED filia nr 1 Wallenroda

Lublin, 20-607, Poland

RECRUITING

Reumatop Grzegorz Rozumek Karin Pistorius Spolka Jawna

Wroclaw, 52-210, Poland

RECRUITING

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WA46440 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 2, 2026

Study Start

June 3, 2026

Primary Completion (Estimated)

July 8, 2033

Study Completion (Estimated)

July 8, 2033

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Locations

US(3)PL(3)