Trials / Completed
CompletedNCT04673591
Effects of Tregalizumab on Allergen-induced Airway Responses and Airway Inflammation in Asthmatic Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- T-Balance Therapeutics GmbH · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The study will be conducted as a randomized, double-blind, placebo-controlled, single-center study in adult patients with mild controlled allergic asthma and house dust mite allergy.
Detailed description
This study will consist of a screening phase, a treatment phase and a follow-up phase. Eligible subjects will undergo a bronchial allergen provocation (BAP) with mite allergen to assess the asthmatic response before and after treatment. Subjects will be randomized to two parallel treatment groups. Each subject will be treated weekly over 12 weeks either with test product or with the reference product (placebo).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tregalizumab | a monoclonal antibody designed for the treatment of allergic asthma indication |
| OTHER | Placebo | Matched Placebo |
Timeline
- Start date
- 2020-12-09
- Primary completion
- 2022-01-12
- Completion
- 2022-01-12
- First posted
- 2020-12-17
- Last updated
- 2022-02-08
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04673591. Inclusion in this directory is not an endorsement.