Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response

NCT04150341 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 01782019-002915-24
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This will be a randomized, double-blind, placebo-controlled study. The study will use a three-period, six-sequence, complete-block, cross-over study design to characterize two doses of inhaled TD-8236 compared to placebo in subjects with mild asthma and a known response to an allergen. Each of the three periods will be 14 days, followed by a washout period before the next period.

Conditions

Asthma

Keywords

TD-8236; Asthma; Proof of concept

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve of Change From Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14

  Values are reported as a weighted mean derived by calculating the AUC change from baseline over the relative time interval, divided by the time interval.

  Day 14 of treatment period: 3 to 8 hours after allergen challenge

Secondary Outcomes (7)

• Area Under the Curve of Percentage Change From Baseline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14

  Day 14 of treatment period: 3 to 8 hours after allergen challenge

• Maximum Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14

  Day 14 of treatment period: 3 to 8 hours after allergen challenge

• Maximum Percentage Decline in Forced Expiratory Volume (in 1 Second) (FEV1) From 3 to 8 Hours After Inhaled Allergen Challenge at Day 14

  Day 14 of treatment period: 3 to 8 hours after allergen challenge

• Area Under the Concentration-time Curve Over One 24-hour Dosing Interval (AUC0-24) of TD-8236 in Plasma

  Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose

• Maximum Observed Plasma Concentration (Cmax) of TD-8236 in Plasma During Dosing Interval

  Day 14 of treatment period: Pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose

Study Arms (3)

TD-8236 Dose A (low dose)

EXPERIMENTAL

TD-8236 Dose A (QD x 14 days)

Drug: TD-8236

TD-8236 Dose B (high dose)

EXPERIMENTAL

TD-8236 Dose B (QD x 14 days)

Drug: TD-8236

Placebo

PLACEBO COMPARATOR

Placebo (QD x 14 days)

Drug: Placebo

Interventions

TD-8236 DRUG

The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.

TD-8236 Dose A (low dose); TD-8236 Dose B (high dose)

Placebo DRUG

The placebo will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 to 65 years of age
• Willing and able to give informed consent and comply with study requirements
• Documented physician-diagnosed asthma for ≥ 4 months prior to Screening
• Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening and weighs ≥ 50 kg at Screening.
• Women of child bearing potential must have a negative pregnancy test
• Males and females must use a highly efficient birth control method
• Pre-bronchodilator FEV1 ≥ 70% predicted
• Documented allergy to at least one common allergen
• Dual responder to inhaled bronchial challenges

You may not qualify if:

• Positive for hepatitis A, B or C, HIV or tuberculosis
• Clinically significant abnormalities of laboratory evaluations
• Have abnormal ECG measurements
• Any sign of respiratory tract infection within 6 weeks of screening
• Have a current bacterial, parasitic, fungal or viral infection
• History of life-threatening asthma
• Uses or have used tobacco or nicotine-containing products within 6 months prior to screening

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (2)

Theravance Biopharma Investigational Site

London, W1G 8HU, United Kingdom

Location

Theravance Biopharma Investigational Site

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Nathan Pfeifer
• Organization: Theravance Biopharma US, Inc

npfeifer@theravance.com

001 (650) 808-3711

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: November 4, 2019
• Study Start: November 6, 2019
• Primary Completion: August 28, 2020
• Study Completion: September 3, 2020
• Last Updated: March 18, 2022
• Results First Posted: March 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)