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NCT Number: NCT06863961

A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis

The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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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 Pesquisas da Clínica IBIS, Salvador, Estado de Bahia, 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

  • AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria at least 1 year prior to screening
  • Moderate to severe AD
  • At least once daily use of an additive-free, bland emollient for at least 7 days prior to the baseline visit and during the study

Exclusion criteria

  • Evidence of other skin conditions that would interfere with the assessment of AD, including, but not limited to, for example cutaneous T-cell lymphoma, allergic contact dermatitis
  • IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasal corticosteroids are allowed) within 4 weeks of the baseline visit and during the study
  • Topical treatment for AD including, but not limited to topical corticosteroids, topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea or filaggrin within 7 days prior to the baseline visit and during the study
  • Any active infection or other active skin diseases that required treatment with parenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2 weeks prior to baseline
  • Acquired or congenital immunodeficiency
  • Systemic therapies that are also used in the treatment of AD, including, but not limited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4 weeks of the baseline visit and during the study

Treatment and study plan

Afimkibart

Drug

Afimkibart will be administered as SC injection.

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

Placebo

Drug

Placebo will be administered as SC injection.

Primary outcomes

  1. Percentage of Participants who Achieve Eczema Area and Severity Index-75 (EASI-75) Response (>= 75% Improvement from Baseline) at Week 16

    Time frame: Baseline and Week 16

Secondary outcomes

  1. Percentage of Participants who Achieve Investigator Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) with >= 2-Grade Improvement at Week 16 and Week 32

    Time frame: At Week 16 and Week 32

  2. Percentage of Participants who Achieve EASI-75 Response at Week 32

    Time frame: At Week 32

  3. Percentage of Participants who Achieve EASI-90 Response at Week 16 and Week 32

    Time frame: At Week 16 and Week 32

  4. Percent Change from Baseline in EASI by Visit

    Time frame: Baseline up to end of study (approximately 1 year)

  5. Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (NRS) Score by Visit

    Time frame: Baseline up to end of study (approximately 1 year)

  6. Change from Baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by Visit

    Time frame: Baseline, weeks 4, 10, 16, 22 and 32

  7. Percentage of EASI-75 Responders at Week 16

    Time frame: At Week 16

  8. Percentage of Participants with Adverse Events

    Time frame: Baseline up to end of study (approximately 1 year)

  9. Serum Concentration of Afimkibart at Specified Timepoints

    Time frame: Weeks 0, 2, 4, 6, 10, 14, 16, 18, 22, 26, 30, 32 and monthly at weeks 4, 8 and 12 after treatment discontinuation.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Patients With Moderate to Severe Atopic Dermatitis

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 7, 2025
Registry last updated
May 11, 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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