A Phase 1c Study of Single Dose MTPS9579A in Patients with Asthma
Research type
Research Study
Full title
A PHASE Ic, MULTICENTER, RANDOMIZED, OBSERVER-BLINDED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF A SINGLE DOSE OF MTPS9579A IN PATIENTS WITH ASTHMA REQUIRING INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER
IRAS ID
258945
Contact name
Peter Bradding
Contact email
Sponsor organisation
Genentech, Inc
Eudract number
2018-003562-14
Duration of Study in the UK
1 years, 7 months, 0 days
Research summary
Research Summary
This is a placebo-controlled, observer-blinded Phase 1c study to see how safe and well-tolerated the experimental drug MTPS9579A is when given in a single dose to patients with asthma who take inhaled corticosteroids (ICS) and a second control medication.\n\nAsthma is a chronic inflammatory disease of the airways that causes coughing, wheezing, and shortness of breath. It affects around 339 million people worldwide, and causes up to 420,000 deaths every year. Despite a number of effective treatments being developed to control asthma, e.g. ICS (inhalers) and other control medications, many patients continue to have uncontrolled symptoms. These patients represent a high, unmet medical need because they have exhausted conventional treatments and have limited options due to the substantial side effects of high-dose ICS and oral corticosteroid treatments. New therapies need to be developed to provide additional treatment options for these patients.\n\nMTPS9579A, the study drug, blocks an enzyme called tryptase that is involved in the inflammatory response in patients with asthma. Tryptase levels have been found to be increased in the lungs of asthmatics, and mutations in this enzyme may be linked to this disease. An ongoing Phase 1 study of MTPS9579A in healthy volunteers has identified no significant safety risks to date, however, this drug has not been tested in patients with asthma.\n\nApproximately 42 patients with asthma will be enrolled during the trial, which will use a single dose of MTPS9579A. Study assessments will include blood and urine sampling, vital signs, physical examination, electrocardiograms, spirometry, injection site inspection, bronchoscopy, asthma control questionnaires, nasosorption, as well as monitoring of adverse events and existing treatment regimens. This study will also look at the effects of MTPS9579A on the body, and how the body processes MTPS9579A, as well as whether MTPS9579A affects disease markers.
Summary of Results
In the 27 people with asthma, the study drug (hereinafter MTPS9579A) did not show any side effects or serious side effects thought to be caused by the study medicine. Researchers thought MTPS9579A was safe and tolerable at the two doses tested – for people with asthma in this study. Researchers found out that MTPS9579A showed some activity in the nose but not in the lungs.
No single study can tell us everything about the risks and benefits of a medicine. It takes a lot of people in many studies to find out everything we need to know. The results from this study may be different from other studies with the same medicine.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0049
Date of REC Opinion
3 May 2019
REC opinion
Further Information Favourable Opinion