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

Roche

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: RO7790121

Study type: Interventional

Funder types: Industry

Identifiers

NCT06863961

2024-515494-95-00 (Other Identifier)

CS45570

Details and patient eligibility

About

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

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 4 patient groups, including a placebo group

RO7790121 Group I

Experimental group

Description:

Participants will receive RO7790121 via subcutaneous (SC) injection.

Treatment:

Drug: RO7790121

RO7790121 Group II

Experimental group

Description:

Participants will receive RO7790121 via SC injection.

Treatment:

Drug: RO7790121

RO7790121 Group III

Experimental group

Description:

Participants will receive RO7790121 via SC injection.

Treatment:

Drug: RO7790121

Placebo

Placebo Comparator group

Description:

Participants will receive placebo via SC injection.

Treatment:

Drug: Placebo