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NCT Number: NCT03747575

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

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.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitatsklinikum Munster, Münster, Germany

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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 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

Treatment and study plan

MSTT1041A

Drug

Participants will receive subcutaneous (SC) MSTT1041A

Other names: astegolimab

Placebo

Drug

Participants will receive SC placebo

Primary outcomes

  1. Percent Change of Total Eczema Area and Severity Index (EASI) Score

    Time frame: Baseline, Week 16

    The Eczema Area and Severity Index (EASI) is a standardized instrument to evaluate the extent and severity of atopic dermatitis. An area score comprised of the percentage of skin affected by eczema for each of 4 body regions (head/neck, trunk, upper extremities, and lower extremities) is calculated with 0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%. Severity is scored for each of the 4 body regions by the summation of the intensity scores for 4 signs (redness, thickness, scratching, and lichenification), with 0 = none/absent, 1 = mild, 2 = moderate, and 3 = severe. The minimum final EASI score is 0 and the maximum score is 72.

Secondary outcomes

  1. Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1

    Time frame: Baseline, Week 16

  2. Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score

    Time frame: Baseline, Week 16

  3. Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS)

    Time frame: Baseline, Week 16

    The Peak Pruritis Numerical Rating Scale (NRS) is a single-item patient-reported outcome (PRO) of itch severity rated on a scale of 0-10, with 0 = no itch and 10 = worst itch imaginable for the prior 24-hour period.

  4. Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement

    Time frame: Baseline, Week 16

  5. Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD)

    Time frame: Baseline, Week 16

    SCORAD is a tool used to assess the extent and severity of eczema based on three aspects of disease severity: extent, intensity, and a subjective (PRO) symptoms. A total score (0-103) is calculated, with higher scores indicating a higher extent and severity of symptoms.

  6. Percentage of Participants With Adverse Events (AE)

    Time frame: Up to Week 24

  7. Serum Concentrations of MSTT1041A

    Time frame: At pre-defined intervals from baseline up to Week 24

  8. Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs)

    Time frame: Up to Week 24

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase II, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of MSTT1041A in Patients With Moderate to Severe Atopic Dermatitis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2018
Registry last updated
May 6, 2023

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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