Clinical trial NCT03747575: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Change of Total Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1
timeFrame: Baseline, Week 16
measure: Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score
timeFrame: Baseline, Week 16
measure: Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS)
timeFrame: Baseline, Week 16
measure: Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement
timeFrame: Baseline, Week 16
measure: Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD)
timeFrame: Baseline, Week 16
measure: Percentage of Participants With Adverse Events (AE)
timeFrame: Up to Week 24
measure: Serum Concentrations of MSTT1041A
timeFrame: At pre-defined intervals from baseline up to Week 24
measure: Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs)
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Allergy & Asthma
state: Alabama
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group - CRN
state: California
city: Los Angeles
country: United States
facility: Jonathan Corren MD, Inc.
state: California
city: Colorado Springs
country: United States
facility: Asthma & Allergy; Associates, P.C.
state: Colorado
city: Miami
country: United States
facility: South Coast Research Center, Inc.
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research, Inc
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Global Clinical Professionals
state: Florida
city: Tampa
country: United States
facility: Forward Clinical Trials
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, LLC
state: Florida
city: Normal
country: United States
facility: Midwest Sinus Allergy and Asthma - CRN
state: Illinois
city: Louisville
country: United States
facility: Dermatology Specialists Research, LLC
state: Kentucky
city: Las Vegas
country: United States
facility: Clinical Research Consortium Nevada
state: Nevada
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialists of New York and New Jersey LLC - Interspond - PPDS
state: New Jersey
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute PC - CRN
state: Oklahoma
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Münster
country: Germany
facility: Universitatsklinikum Munster
city: Krakow
country: Poland
facility: Centrum Medyczne ALL-MED
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
city: Rzeszow
country: Poland
facility: Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina; Klinika Dermatologii
city: Szczecin
country: Poland
facility: Laser Clinic
city: Wroc?aw
country: Poland
facility: Wro Medica
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: