A Study to Assess the Efficacy and Safety of MSTT1041A in Patients with Uncontrolled Severe Asthma

• Register: EUCTR
• Last refreshed on: 25 May 2020
• Main ID: EUCTR2016-001549-13-PL
• Date of registration: 28/09/2016
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: A Study to Assess the Efficacy and Safety of MSTT1041A in Patients with Uncontrolled Severe Asthma
• Scientific title: A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO ASSESS THE EFFICACY AND SAFETY OF MSTT1041A IN PATIENTS WITH UNCONTROLLED SEVERE ASTHMA
• Date of first enrolment: 04/10/2016
• Target sample size: 501
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001549-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: yes; Other trial design description: DOSE-RANGING STUDY; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Belgium, Bulgaria, Canada, Czech Republic, Germany, Korea, Republic of, New Zealand, Peru, Poland, Romania, Russian Federation, South Africa, Ukraine, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: Genentech Inc. c/o F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- Age 18-75 years
- Body mass index (BMI) of 18-38 kg/square meter (kg/m2) and weight >= 40 kg at screening
- Documented physician-diagnosed asthma
- On high dose inhaled corticosteroid (ICS) therapy plus at least one additional allowed controller medication
- Forced expiratory volume in 1 second (FEV1) of 40%-80% of predicted
- Evidence of uncontrolled asthma
- Use of contraceptive measures

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 401
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion criteria:
- Diagnosis of mimics of asthma
- Diagnosis of occupational asthma, aspirin-sensitive asthma, asthma-chronic obstructive pulmonary disease overlap syndrome, or bronchiolitis, as determined by the investigator
- Pregnant or lactating, or intending to become pregnant during the study or within 20 weeks after the last dose of MSTT1041A
- Recent history of smoking
- 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
- Asthma exacerbation within 4 weeks prior to screening
- Intubation for respiratory failure due to asthma within 12 months prior to screening
- Comorbid conditions that may interfere with evaluation of investigational medicinal product
- Known sensitivity to any of the active substances or their excipients to be administered during dosing
- Positive pregnancy test
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Uncontrolled Severe Asthma
MedDRA version: 20.0 Level: LLT Classification code 10003560 Term: Asthma NOS System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10015888 Term: Extrinsic asthma System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10003561 Term: Asthma, unspecified System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10003554 Term: Asthma aggravated System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10068393 Term: Neutrophilic asthma System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10022847 Term: Intrinsic asthma System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10074614 Term: Nocturnal asthma System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10068463 Term: Paucigranulocytic asthma System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10003638 Term: Atopic asthma System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10009029 Term: Chronic obstructive asthma (with obstructive pulmonary disease), w/o-ment of status asthmaticus System Organ Class: 100000004855
MedDRA version: 20.0 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855

Intervention(s)

Product Name: MSTT1041A
Product Code: Ro 718-7807/F01
Pharmaceutical Form: Solution for injection
INN or Proposed INN: n.a.
Current Sponsor code: RO7187807
Other descriptive name: MSTT1041A, anti- ST2 (IgG2) human monoclonal antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Efficacy:
1. Incidence of asthma exacerbations

Secondary Objective: • To evaluate the safety and efficacy of MSTT1041A compared with placebo
• To evaluate the pharmacokinetics (PK) of MSTT1041A
• To evaluate the immune response to MSTT1041A

Main Objective: • To evaluate the efficacy of MSTT1041A compared with placebo

Timepoint(s) of evaluation of this end point: 1. Week 54

Secondary Outcome(s)

Secondary end point(s): Efficacy:
1. Change in pre-bronchodilator FEV1
2. Time to first asthma exacerbation during the 52-week double blind
treatment period
3. Achievement of improvement from baseline visit in ACQ-5 score
4. Change in patient-reported use of short-acting rescue therapy
5. Proportion of weeks without patient-reported asthma-related night
time awakenings
6. Change in patient-reported daytime asthma symptoms
7. Achievement of improvement in AQLQ(S) score from baseline to Week 54
Safety:
8. Incidence and severity of adverse events
9. Change in physical examination findings, vital signs, ECGs, and clinical
laboratory results
10. Incidence of anti-drug antibodies (ADAs)
PK
11. Serum concentration of MSTT1041A
Immunogenicity
12. Incidence of treatment-emergent ADAs

Timepoint(s) of evaluation of this end point: 1. Week 54
2. Up to Week 54
3-4. Week 54
5. Up to Week 54
6-7. Week 54
8-9. Up to Week 70
10. Up to Week 70
11. Up to Week 70
12. Up to Week 70

Secondary ID(s)

GB39242

2016-001549-13-BE

Source(s) of Monetary Support

Genentech Inc. c/o F. Hoffmann-La Roche Ltd

Ethics review

Status: Approved
Approval date: 13/09/2016
Contact: