NCT07223697

Brief Summary

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.

Trial Health

83
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

Timeline
80mo left

Started Jan 2026

Longer than P75 for phase_2

Geographic Reach
6 countries

24 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 Progress8%
Jan 2026Mar 2033

First Submitted

Initial submission to the registry

October 30, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 8, 2026

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2033

Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

7.1 years

First QC Date

October 30, 2025

Last Update Submit

July 3, 2026

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants with Adverse Events

    From Baseline up to 6 years

Secondary Outcomes (11)

  • Change From Baseline (in Parent Study) in Eczema Area and Severity Index (EASI) Score at Each Visit

    Baseline, Up to 6 years

  • Percent Change From Baseline (in Parent Study) in EASI Score at Each Visit

    Baseline, Up to 6 years

  • Percentage of Participants With EASI-50 at Each Visit

    Up to 6 years

  • Percentage of Participants with EASI-75 at Each Visit

    Up to 6 years

  • Percentage of Participants with EASI-90 at Each Visit

    Up to 6 years

  • +6 more secondary outcomes

Study Arms (2)

Afimkibart Group I

EXPERIMENTAL

Participants will receive Afimkibart as subcutaneous (SC) injection.

Drug: Afimkibart

Afimkibart Group II

EXPERIMENTAL

Participants will receive Afimkibart as SC injection.

Drug: Afimkibart

Interventions

AfimkibartDRUG

Afimkibart SC injection will be administered as per the schedule defined in the protocol.

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

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Hamilton Research, LLC

Alpharetta, Georgia, 30022, United States

RECRUITING

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

RECRUITING

Best Skin Research LLC

Camp Hill, Pennsylvania, 17011, United States

RECRUITING

Centro de Estudos em Terapias Inovadoras ? CETI

Curitiba, Paraná, 80030-110, Brazil

RECRUITING

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

RECRUITING

Hospital de Clnicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

Botucatu, São Paulo, 18618-686, Brazil

RECRUITING

Centro de Pesquisa São Lucas

Campinas, São Paulo, 13060-803, Brazil

RECRUITING

HMCG - Hospital e Maternidade Dr. Christovo da Gama

Santo Andr, São Paulo, 09030-010, Brazil

RECRUITING

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

Sao Jose Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

Rio de Janeiro, 20241-180, Brazil

RECRUITING

DermEffects

London, Ontario, N6H 5L5, Canada

RECRUITING

Lynderm Research Inc

Markham, Ontario, L3P 1X3, Canada

RECRUITING

DermEdge

Mississauga, Ontario, L4Y4C5, Canada

RECRUITING

Ryan Clinical Research Inc

Newmarket, Ontario, L3Y 5G8, Canada

RECRUITING

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony, 48455, Germany

RECRUITING

Dermatologikum Hamburg Gemeinschaftspraxis GbR

Hamburg, 20354, Germany

RECRUITING

Centrum Medyczne Pratia Katowice I

Katowice, Silesian Voivodeship, 40-081, Poland

RECRUITING

Centrum Medyczne Pratia Gdynia

Gdynia, 81-338, Poland

RECRUITING

Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski

Krakow, 30-002, Poland

RECRUITING

Centrum Nowoczesnych Terapii "Dobry Lekarz"

Krakow, 31-011, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie

Rzeszów, 35-055, Poland

RECRUITING

Klinika Ambroziak Dermatologia

Warsaw, 02-953, Poland

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: CS45943 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728 (U.S. Only)global-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
NON 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

October 30, 2025

First Posted

November 3, 2025

Study Start

January 8, 2026

Primary Completion (Estimated)

March 1, 2033

Study Completion (Estimated)

March 1, 2033

Last Updated

July 7, 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

ES(1)DE(2)BR(8)US(3)PL(6)CA(4)