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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: MSTT1041A; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Münster, Germany, 48149
    • Universitätsklinikum Münster
• Poland
  • Krakow, Poland, 30-033
    • Centrum Medyczne ALL-MED
  • Lodz, Poland, 90-153
    • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Rzeszow, Poland, 35-055
    • Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina; Klinika Dermatologii
  • Szczecin, Poland, 70-322
    • Laser Clinic
  • Wroc?aw, Poland, 51-685
    • Wro Medica
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Alabama Allergy & Asthma
  • California
    • Los Angeles, California, United States, 90025
      • California Allergy and Asthma Medical Group - CRN
    • Los Angeles, California, United States, 90025
      • Jonathan Corren MD, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma & Allergy; Associates, P.C.
  • Florida
    • Miami, Florida, United States, 33136
      • South Coast Research Center, Inc.
    • North Miami Beach, Florida, United States, 33162
      • Harmony Clinical Research, Inc
    • Saint Petersburg, Florida, United States, 33702
      • GCP Global Clinical Professionals
    • Tampa, Florida, United States, 33624
      • Forward Clinical Trials
    • Winter Park, Florida, United States, 32789
      • Florida Pulmonary Research Institute, LLC
  • Illinois
    • Normal, Illinois, United States, 61761
      • Midwest Sinus Allergy and Asthma - CRN
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Dermatology Specialists Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium Nevada
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Skin Laser and Surgery Specialists of New York and New Jersey LLC - Interspond - PPDS
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute PC - CRN
  • Texas
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Participants will receive MSTT1041A	Drug: MSTT1041A; Participants will receive subcutaneous (SC) MSTT1041A; Other Names: astegolimab
Placebo Comparator: Placebo; Participants will receive placebo matched to MSTT1041A	Drug: Placebo; Participants will receive SC placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change of Total Eczema Area and Severity Index (EASI) Score	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.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Concentrations of MSTT1041A		At pre-defined intervals from baseline up to Week 24
Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs)		Up to Week 24
Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1		Baseline, Week 16
Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score		Baseline, Week 16
Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS)	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.	Baseline, Week 16
Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement		Baseline, Week 16
Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD)	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.	Baseline, Week 16
Percentage of Participants With Adverse Events (AE)		Up to Week 24

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): March 11, 2020
• Study Completion (Actual): May 5, 2020

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Anti-Infective Agents; Antiviral Agents; Anti-Inflammatory Agents; Tumor Necrosis Factor Inhibitors; Astegolimab
• Other Study ID Numbers: GS40965; 2018-003429-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com).

Further details on Roche's criteria for eligible studies are available here: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No