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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MSTT1041A
Placebo
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Allergy & Asthma
  • California Allergy and Asthma Medical Group - CRN
  • Jonathan Corren MD, Inc.
  • Asthma & Allergy; Associates, P.C.
  • South Coast Research Center, Inc.
  • Harmony Clinical Research, Inc
  • GCP Global Clinical Professionals
  • Forward Clinical Trials
  • Florida Pulmonary Research Institute, LLC
  • Midwest Sinus Allergy and Asthma - CRN
  • Dermatology Specialists Research, LLC
  • Clinical Research Consortium Nevada
  • Skin Laser and Surgery Specialists of New York and New Jersey LLC - Interspond - PPDS
  • Vital Prospects Clinical Research Institute PC - CRN
  • Center for Clinical Studies
  • Universitatsklinikum Munster
  • Centrum Medyczne ALL-MED
  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina; Klinika Dermatologii
  • Laser Clinic
  • Wro Medica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Participants will receive MSTT1041A

Participants will receive placebo matched to MSTT1041A

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1
Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score
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.
Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement
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.
Percentage of Participants With Adverse Events (AE)
Serum Concentrations of MSTT1041A
Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs)

Full Information

First Posted
November 16, 2018
Last Updated
April 11, 2023
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03747575
Brief Title
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
May 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Allergy & Asthma
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
California Allergy and Asthma Medical Group - CRN
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Jonathan Corren MD, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Asthma & Allergy; Associates, P.C.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
South Coast Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Harmony Clinical Research, Inc
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
GCP Global Clinical Professionals
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
Forward Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Florida Pulmonary Research Institute, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Midwest Sinus Allergy and Asthma - CRN
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Dermatology Specialists Research, LLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Clinical Research Consortium Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Skin Laser and Surgery Specialists of New York and New Jersey LLC - Interspond - PPDS
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Vital Prospects Clinical Research Institute PC - CRN
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Universitatsklinikum Munster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Centrum Medyczne ALL-MED
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina; Klinika Dermatologii
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Laser Clinic
City
Szczecin
ZIP/Postal Code
70-322
Country
Poland
Facility Name
Wro Medica
City
Wroc?aw
ZIP/Postal Code
51-685
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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