NCT03747575

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_2

Geographic Reach
3 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 6, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2020

Completed
3 years until next milestone

Results Posted

Study results publicly available

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

November 16, 2018

Results QC Date

March 2, 2023

Last Update Submit

April 11, 2023

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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)

    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)

    Baseline, Week 16

  • +3 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Participants will receive MSTT1041A

Drug: MSTT1041A

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to MSTT1041A

Drug: Placebo

Interventions

MSTT1041ADRUG

Participants will receive subcutaneous (SC) MSTT1041A

Also known as: astegolimab
Treatment
PlaceboDRUG

Participants will receive SC placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Alabama Allergy & Asthma

Birmingham, Alabama, 35209, United States

Location

California Allergy and Asthma Medical Group - CRN

Los Angeles, California, 90025, United States

Location

Jonathan Corren MD, Inc.

Los Angeles, California, 90025, United States

Location

Asthma & Allergy; Associates, P.C.

Colorado Springs, Colorado, 80907, United States

Location

South Coast Research Center, Inc.

Miami, Florida, 33136, United States

Location

Harmony Clinical Research, Inc

North Miami Beach, Florida, 33162, United States

Location

GCP Global Clinical Professionals

St. Petersburg, Florida, 33702, United States

Location

Forward Clinical Trials

Tampa, Florida, 33624, United States

Location

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, 32789, United States

Location

Midwest Sinus Allergy and Asthma - CRN

Normal, Illinois, 61761, United States

Location

Dermatology Specialists Research, LLC

Louisville, Kentucky, 40241, United States

Location

Clinical Research Consortium Nevada

Las Vegas, Nevada, 89119, United States

Location

Skin Laser and Surgery Specialists of New York and New Jersey LLC - Interspond - PPDS

Hackensack, New Jersey, 07601, United States

Location

Vital Prospects Clinical Research Institute PC - CRN

Tulsa, Oklahoma, 74136, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Universitatsklinikum Munster

Münster, 48149, Germany

Location

Centrum Medyczne ALL-MED

Krakow, 30-033, Poland

Location

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

Lodz, 90-153, Poland

Location

Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina; Klinika Dermatologii

Rzeszów, 35-055, Poland

Location

Laser Clinic

Szczecin, 70-322, Poland

Location

Wro Medica

Wroc?aw, 51-685, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

astegolimab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
1-800-821-8590

Study Officials

  • Clinical Trials

    Genentech, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 20, 2018

Study Start

February 6, 2019

Primary Completion

March 11, 2020

Study Completion

May 5, 2020

Last Updated

May 6, 2023

Results First Posted

May 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

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

Locations

US(15)DE(1)PL(5)