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NCT Number: NCT07223697

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro de Estudos em Terapias Inovadoras ? CETI, Curitiba, Paraná, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Afimkibart

Drug

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

Other names: RO7790121, PF-06480605, RVT-3101

Primary outcomes

  1. Percentage of Participants with Adverse Events

    Time frame: From Baseline up to 6 years

Secondary outcomes

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

    Time frame: Baseline, Up to 6 years

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

    Time frame: Baseline, Up to 6 years

  3. Percentage of Participants With EASI-50 at Each Visit

    Time frame: Up to 6 years

  4. Percentage of Participants with EASI-75 at Each Visit

    Time frame: Up to 6 years

  5. Percentage of Participants with EASI-90 at Each Visit

    Time frame: Up to 6 years

  6. 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

  7. Change from Baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at Each Visit

    Time frame: Baseline, Up to 6 years

  8. Change from Baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at Each Visit

    Time frame: Baseline, Up to 6 years

  9. 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

  10. Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart

    Time frame: From Baseline up to 6 years

  11. Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart

    Time frame: From Baseline up to 6 years

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Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: Velarite-LTE

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Nov 3, 2025
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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