Study Examining PrEP-001 in Subjects With Asthma

NCT03296917 | Completed Phase 2

• 1 other identifier: PrEP-CS-002
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Phase 2 study, to examine the prophylactic efficacy, safety and tolerability of PrEP-001 in asthmatics who have been infected with the human rhinovirus (HRV16) after receiving two doses of the study drug/placebo.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Endpoint: The Area Under the Curve (AUC) of total symptom score post viral challenge.

  AUC of total symptom scores (upper respiratory tract (URT), lower respiratory tract (LRT) and systemic viral symptoms (SVS)). Total symptom scores (from the symptom diary card) used to calculate the AUC. The primary endpoint is only being derived from the Viral Challenge arm.

  Day -14 to Day 28

Secondary Outcomes (30)

• Secondary Efficacy Endpoint: Symptom Scores: Area Under the Curve (AUC)

  Day -4 to Day 28

• Secondary Efficacy Endpoint: Symptom Scores: Duration of symptoms

  Day -4 to Day 28

• Secondary Efficacy Endpoint: Symptom Scores: Peak symptoms score

  Day -4 to Day 28

• Secondary Efficacy Endpoint: Symptom Scores: Time to peak symptoms

  Day -4 to Day 28

• Secondary Efficacy Endpoint: Symptom Scores: Time to resolution from peak symptoms

  Day -4 to Day 28

Other Outcomes (28)

• Exploratory Efficacy Analysis: Proportion (on any occasion) of subjects with Grade 2 or worse symptoms at any day post-Viral Challenge.

  Day -14 to Day 28

• Exploratory Efficacy Analysis: Proportion of subjects with Grade 2 or worse symptoms at each day post-Viral Challenge.

  Day -4 to Day 28

• Exploratory Efficacy Analysis: Duration of Grade 2 or worse symptoms (post-Viral Challenge).

  Day -4 to Day 28

Study Arms (2)

IMP - PrEP-001

EXPERIMENTAL

In Viral Challenge arm cohort: A nasal dose of 6400 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1). In the Safety arm's first dose cohort: A nasal dose of 6400 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1). Then assuming no significant safety issues with the lower dose (as determined by blinded review by the DSMB team), the Safety arm's second dose cohort will consist of: A nasal dose of 12800 μg PrEP-001 equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1)

Drug: PrEP-001

Placebo - G-004

PLACEBO COMPARATOR

In the Viral Challenge arm and each Safety Arm cohort: A nasal dose of placebo equally divided over both nostrils on 2 consecutive days (Day -2 and Day -1).

Drug: G-004

Interventions

PrEP-001 DRUG

A spray dried powder for intranasal administration formulated from an aqueous mixture of pre-gelatinized waxy maize starch and the drug substance delivered using a single dose nasal powder device.

IMP - PrEP-001

G-004 DRUG

A spray dried pre-gelatinized waxy maize starch powder (G-001) in the single dose nasal powder device

Placebo - G-004

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 55 years on the day of first dosing with IMP.
• Physician diagnosed asthma for at least 6 months prior to Screening and using treatment equivalent up to and including Global Initiative for Asthma (GINA) Stage 3.
• In good health with no history of major medical conditions (other than asthma) that will interfere with subject safety, as defined by medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation.

You may not qualify if:

• Any ex-smoker or smoker with a history of more than 10 pack-years.
• History of life-threatening asthma, Diagnosis of COPD as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines.
• Any history or evidence of any clinically significant medical and psychiatric conditions

Sponsors & Collaborators

• Hvivo: lead
• Prep Biopharm Limited: collaborator

MeSH Terms

Conditions

Asthma

Interventions

G004 compound

Condition Hierarchy (Ancestors)

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

Study Officials

• John Efthimiou

  Sponsor's Representative

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: September 29, 2017
• Study Start: December 11, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 29, 2017

Record last verified: 2017-09