A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis

Genentech

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: MSTT1041A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03747575

GS40965

2018-003429-27 (EudraCT Number)

Details and patient eligibility

About

This study will assess the efficacy and safety of MSTT1041A (astegolimab) in participants with moderate to severe atopic dermatitis (AD). The study consists of a screening period, a 16-week treatment period, and an 8-week follow-up period.

Enrollment: 65 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Ability to comply with the study protocol
• Chronic AD that has been present for at least 3 years before the screening visit
• Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications (medications or treatments applied directly to part of the body) or for whom topical treatments are otherwise medically inadvisable

Exclusion criteria

• Prior treatment with MSTT1041A
• Treatment with any investigational therapy (with the exception of biologics) within 8 weeks or within 5 half-lives whichever is longer, before screening
• Treatment with any cell-depleting agents within 6 months before screening, or until lymphocyte count returns to normal, whichever is longer
• Treatment with other biologics within 3 months or 5 half-lives before screening, whichever is longer
• Comorbid conditions that may interfere with evaluation of investigational medicinal product
• History or evidence of substance abuse that would pose a risk to participant safety, interfere with the conduct of the study, have an impact on the study results, or affect the participant's ability to participate in the study
• History of anaphylaxis, hypersensitivity to a biologic agent, or known hypersensitivity to any component of the MSTT1041A or placebo injection
• Planned surgical intervention during the course of the study
• Pregnant or breastfeeding, or intending to become pregnant during the study
• Participant who is a member of the investigational team or his/her immediate family

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Participants will receive MSTT1041A

Treatment:

Drug: MSTT1041A

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to MSTT1041A

Treatment:

Drug: Placebo