A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis (Velarite-LTE)

June 5, 2026 updated by: Hoffmann-La Roche

An Extension Study To Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Atopic Dermatitis Who Participated in Previous Afimkibart Clinical Trials

This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20241-180
        • Recruiting
        • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Recruiting
        • Centro de Estudos em Terapias Inovadoras ? CETI
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
    • São Paulo
      • Campinas, São Paulo, Brazil, 13060-803
        • Recruiting
        • Centro de Pesquisa Sao Lucas
  • Canada
    • Ontario
      • London, Ontario, Canada, N6H 5L5
        • Recruiting
        • DermEffects
      • Mississauga, Ontario, Canada, L4Y4C5
        • Recruiting
        • DermEdge
  • Germany
      • Hamburg, Germany, 20354
        • Recruiting
        • Dermatologikum Hamburg Gemeinschaftspraxis GbR
  • Poland
      • Gdynia, Poland, 81-338
        • Recruiting
        • Centrum Medyczne Pratia Gdynia
      • Krakow, Poland, 31-011
        • Recruiting
        • Centrum Nowoczesnych Terapii "Dobry Lekarz"
      • Krakow, Poland, 30-002
        • Recruiting
        • Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski
      • Rzeszów, Poland, 35-055
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie
      • Warsaw, Poland, 02-953
        • Recruiting
        • Klinika Ambroziak Dermatologia
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-081
        • Recruiting
        • Centrum Medyczne Pratia Katowice I
  • United States
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Recruiting
        • Hamilton Research, LLC
    • Michigan
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Revival Research Institute, LLC
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Recruiting
        • Best Skin Research LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ability and willingness to comply with all aspects of the protocol including completion of the efficacy assessments (EASI and IGA), clinical outcome assessment instruments (DLQI, POEM), and safety and PK sample collections for the duration of the study

Parent Clinical Trial-Specific Criteria:

  • Study CS45570 participants who continued to be evaluated at the Week 36 follow up visit and achieved => EASI50 response from study baseline

Exclusion Criteria:

  • Evidence of other skin conditions that would interfere with the assessment of AD
  • Withdrawal of consent and/or premature discontinuation from parent study
  • Any permanent discontinuation of study drug in parent study
  • History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of Afimkibart

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Afimkibart Group I
Participants will receive Afimkibart as subcutaneous (SC) injection.
Drug: Afimkibart
Afimkibart SC injection will be administered as per the schedule defined in the protocol.
Other Names:
  • RVT-3101
  • PF-06480605
  • RO7790121
Experimental: Afimkibart Group II
Participants will receive Afimkibart as SC injection.
Drug: Afimkibart
Afimkibart SC injection will be administered as per the schedule defined in the protocol.
Other Names:
  • RVT-3101
  • PF-06480605
  • RO7790121

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events
Time Frame: From Baseline up to 6 years
From Baseline up to 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline (in Parent Study) in Eczema Area and Severity Index (EASI) Score at Each Visit
Time Frame: Baseline, Up to 6 years
Baseline, Up to 6 years
Percent Change From Baseline (in Parent Study) in EASI Score at Each Visit
Time Frame: Baseline, Up to 6 years
Baseline, Up to 6 years
Percentage of Participants With EASI-50 at Each Visit
Time Frame: Up to 6 years
Up to 6 years
Percentage of Participants with EASI-75 at Each Visit
Time Frame: Up to 6 years
Up to 6 years
Percentage of Participants with EASI-90 at Each Visit
Time Frame: Up to 6 years
Up to 6 years
Percentage of Participants who Achieve Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of Clear (0) or Almost clear (1) at Each Visit
Time Frame: From Baseline up to 6 years
From Baseline up to 6 years
Change from Baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at Each Visit
Time Frame: Baseline, Up to 6 years
Baseline, Up to 6 years
Change from Baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at Each Visit
Time Frame: Baseline, Up to 6 years
Baseline, Up to 6 years
Serum Concentration of Afimkibart at Specified Timepoints
Time Frame: Pre-dose on Day 1, Weeks 2, 10, 18, 26, 34, 42, 50 74, 98, 122, 146, 170, 194, 218, 242, 266, 290 and 14 weeks after last dose
Pre-dose on Day 1, Weeks 2, 10, 18, 26, 34, 42, 50 74, 98, 122, 146, 170, 194, 218, 242, 266, 290 and 14 weeks after last dose
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart
Time Frame: From Baseline up to 6 years
From Baseline up to 6 years
Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart
Time Frame: From Baseline up to 6 years
From Baseline up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2026

Primary Completion (Estimated)

March 1, 2033

Study Completion (Estimated)

March 1, 2033

Study Registration Dates

First Submitted

October 30, 2025

First Submitted That Met QC Criteria

October 30, 2025

First Posted (Actual)

November 3, 2025

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS45943
  • 2025-520771-59-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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