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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03747575
• Other study ID #: GS40965
• Secondary ID: 2018-003429-27
• Status: Completed
• Phase: Phase 2
• Start date: February 6, 2019
• Est. completion date: May 5, 2020

Study information

• Verified date: April 2023
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 5, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• MSTT1041A
Participants will receive subcutaneous (SC) MSTT1041A
• Placebo
Participants will receive SC placebo

Locations

Country	Name	City	State
Germany	Universitatsklinikum Munster	Münster
Poland	Centrum Medyczne ALL-MED	Krakow
Poland	SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi	Lodz
Poland	Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina; Klinika Dermatologii	Rzeszow
Poland	Laser Clinic	Szczecin
Poland	Wro Medica	Wroc?aw
United States	Alabama Allergy & Asthma	Birmingham	Alabama
United States	Asthma & Allergy; Associates, P.C.	Colorado Springs	Colorado
United States	Skin Laser and Surgery Specialists of New York and New Jersey LLC - Interspond - PPDS	Hackensack	New Jersey
United States	Center for Clinical Studies	Houston	Texas
United States	Clinical Research Consortium Nevada	Las Vegas	Nevada
United States	California Allergy and Asthma Medical Group - CRN	Los Angeles	California
United States	Jonathan Corren MD, Inc.	Los Angeles	California
United States	Dermatology Specialists Research, LLC	Louisville	Kentucky
United States	South Coast Research Center, Inc.	Miami	Florida
United States	Midwest Sinus Allergy and Asthma - CRN	Normal	Illinois
United States	Harmony Clinical Research, Inc	North Miami Beach	Florida
United States	GCP Global Clinical Professionals	Saint Petersburg	Florida
United States	Forward Clinical Trials	Tampa	Florida
United States	Vital Prospects Clinical Research Institute PC - CRN	Tulsa	Oklahoma
United States	Florida Pulmonary Research Institute, LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1		Baseline, Week 16
Secondary	Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score		Baseline, Week 16
Secondary	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
Secondary	Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement		Baseline, Week 16
Secondary	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
Secondary	Percentage of Participants With Adverse Events (AE)		Up to Week 24
Secondary	Serum Concentrations of MSTT1041A		At pre-defined intervals from baseline up to Week 24
Secondary	Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs)		Up to Week 24