A Study to Assess the Efficacy and Safety of MSTT1041A in Patients with Moderate to Severe Atopic Dermatitis
- Conditions
- Moderate to severe atopic dermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-003429-27-DE
- Lead Sponsor
- Genentech Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 65
- Age 18-75 years
- 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 or for whom topical treatments are otherwise medically inadvisable
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 88
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
- 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 investigational or licensed biologics as follows:
Any cell-depleting agents including but not limited to rituximab: within 6 months before screening, or until lymphocyte count returns to normal, whichever is longer
Other biologics: within 3 months or 5 half-lives before screening, whichever is longer
- Certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit
- Comorbid conditions that may interfere with evaluation of investigational medicinal product
- History or evidence of substance abuse that would pose a risk to patient safety, interfere with the conduct of the study, have an impact on the study results, or affect the patient'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
- Patient who is a member of the investigational team or his/her immediate family
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To evaluate the efficacy of MSTT1041A compared with placebo on basis of total Eczema area and severity index (EASI) score;Secondary Objective: •To evaluate the efficacy of MSTT1041A compared with placebo on basis of Investigator's global assessment (IGA), EASI-75, Numeric rating scale (NRS), body surface area (BSA) and by SCORing Atopic dermatitis (SCORAD)<br>•To evaluate the safety of MSTT1041A compared with placebo on the basis of adverse events, vital signs, electrocardiogram (ECG)s, and clinical laboratory results<br>•To characterize the MSTT1041A pharmacokinetic (PK) profile on the basis of serum concentration<br>•To evaluate the immune response to MSTT1041A on the basis of anti-drug antibodies (ADAs)<br>;Primary end point(s): 1)Percent change from baseline to Week 16 of total EASI score;Timepoint(s) of evaluation of this end point: 1. Baseline (Day 1), Week 16
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1)Proportion of patients who achieve IGA response of 0 or 1 (clear or almost clear) at Week 16<br>2)Proportion of patients who achieve EASI-75 (>= 75% reduction from baseline in EASI score) at Week 16<br>3)Percent change in pruritus from baseline to Week 16, as assessed by a NRS<br>4)Percent change in BSA with AD involvement from baseline to Week 16<br>5)Percent change in disease severity from baseline to Week 16, as assessed by SCORAD<br>6)Incidence and severity of adverse events<br>7)Change from randomization visit in vital signs, ECGs, and clinical laboratory results<br>8)Serum concentrations of MSTT1041A<br>9)Incidence of treatment-emergent ADAs during the study<br>10)Potential impact of ADA status on efficacy, safety, and PK endpoints<br>;Timepoint(s) of evaluation of this end point: 1-2. Baseline, Week 16<br>3-5. Baseline, Week 16<br>6-10. Up to Week 24<br>