A Phase IIa Repeat Dose AXP1275 vs Placebo Cross-over Trial With Pulmonary Allergen Challenge in Adults With Asthma

NCT01890161 | Completed Phase 2

• 1 other identifier: AXP1275-201
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief Summary

This is the first study in human patients with asthma that the sponsor is conducting in order to evaluate if there are signals that the investigational medication, AXP1275, may be a safe and effective treatment for asthma. The results of this study may help the sponsor to design additional studies.

Conditions

Atopic Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• Late Asthmatic Response

  Area under the forced expiratory volume in 1 second (FEV1) curve from 3 to 7 hours after allergen challenge (AUC3-7h) on day 13 of both 14-day treatment periods.

  From 3 to 7 hours after allergen challenge on day 13 of both 14-day treatment periods

Secondary Outcomes (10)

• Early Asthmatic Response

  Between 0 to 2 hours after allergen challenge on day 13 of both 14-day treatment periods

• Late Asthmatic Response-Secondary

  Between 3 to 7 hours after allergen challenge on day 13 of both 14-day treatment periods

• Total Asthmatic Response

  Between 0 to 7 hours after allergen challenge on day 13 of both 14-day treatment periods

• FEV1 comparison

  At day 12, 13, and 14 of both 14-day treatment periods

• Sputum eosinophil count

  On days 12, 13, and 14 of both 14-day treatment periods

Other Outcomes (3)

• Adverse events (AEs)

  Throughout both 14-day treatment periods

• Clinical laboratory, vital signs, physical examination, and ECG changes

  Baseline to the end of the study (14 +/- 3 days from the last of two treatments)

• AXP1275 plasma concentrations

  day 6 or 7 (predose), day 12 (3 hr post dose), day 13 (3 and 10 hr post dose), and day 14 (3 hr post dose) for the active treatment arm

Study Arms (2)

AXP1275

EXPERIMENTAL

AXP1275 50 mg (2 × 25-mg capsules) once daily for 14 days

Drug: AXP1275

AXP1275 matching placebo

PLACEBO COMPARATOR

AXP1275 matching placebo (2 capsules) once daily for 14 days

Drug: AXP1275 matching placebo

Interventions

AXP1275 DRUG

AXP1275 50 mg (2 × 25-mg capsules)

AXP1275

AXP1275 matching placebo DRUG

AXP1275 matching placebo (2 capsules)

AXP1275 matching placebo

Eligibility Criteria

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

You may qualify if:

• Age 18 to 64 years (inclusive).
• Male or female.
• If male, is surgically sterile (vasectomy) or agrees to comply with required contraceptive measures.
• If female, not pregnant (or lactating), as evidenced by a negative serum pregnancy test, and is either surgically sterile (hysterectomy, bilateral ovariectomy, or bilateral tubal ligation), or if a female of childbearing potential, agrees to comply with required contraceptive measures.
• History of episodic wheeze and shortness of breath with a prebronchodilator FEV1 ≥70% of predicted at screening.
• Asthma symptoms treated (if necessary) only with intermittent short-acting ß-agonist therapy by inhalation.
• Demonstration of a positive wheal reaction on skin prick testing to at least 1 common aeroallergen at screening.
• Screening inhalational allergen challenge response demonstrating that the subject experiences both an early asthmatic response (EAR) and a late asthmatic response (LAR).
• Methacholine PC20 ≤16 mg/mL at screening.
• No history of smoking within 6 months of screening, and with a total pack year history of ≤10 pack years.
• lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the investigator.
• All values for hematology, clinical chemistry, and urinalysis within the normal range, or if abnormal, are deemed not clinically significant by the investigator with documented agreement from the medical monitor.
• Is able to give written informed consent.

You may not qualify if:

• Past or present disease which, as judged by the investigator, may affect the outcome of this study.
• Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the screening period.
• Symptomatic allergic rhinitis. Those subjects with a history of allergic rhinitis may participate if asymptomatic at screening (and continue to be so at baseline on Day 1 prior to dosing) and if, in the opinion of the investigator, it is unlikely that disease exacerbation will occur during the course of the study.
• History of life-threatening asthma.
• Abnormal chest X-ray.
• Use of oral, injectable, or dermal steroids within 3 months and/or inhaled steroids within 1 month of screening.
• Use of cromoglycate, nedocromil, leukotriene receptor antagonists (zafirlukast, pranlukast, montelukast), and inhibitors of 5-lipoxygenase (zileuton) within 4 weeks of screening.
• Use of immunosuppressives, anticoagulants (warfarin or heparin), or any medications that may interact with pharmacodynamic (PD) effects of AXP1275 within 4 weeks of screening.
• Use of theophylline-containing agents (any type) and long-acting β2-agonists (salmeterol, formoterol) within 4 weeks of screening.
• Positive screen for drug(s) of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, or benzodiazepines) or cotinine.
• Positive for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV) 1/2.
• Has participated in a clinical trial and has received an investigational product within 30 days prior to screening, or 5 elimination half lives of the investigational product, whichever is longer.
• Has had significant blood loss (\>500 mL) or donation of blood within 2 months prior to screening visit 1.
• History of being unable to tolerate or complete methacholine or allergen challenge tests.
• Subject is undergoing allergen desensitization therapy.

Sponsors & Collaborators

• Axikin Pharmaceuticals, Inc.: lead

Study Sites (3)

Vancouver General Hospital, The Lung Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

IUCPQ, Institut de cardiologie et de pneumologie de l'Hôpital Laval

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

AXP1275

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul O'Byrne, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Louis-Philippe Boulet, MD

  IUCPQ, Institut de cardiologie et de pneumologie de l'Hôpital Laval

  PRINCIPAL INVESTIGATOR

• Mark Fitzgerald, MD

  University of British Columbia, Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 1, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: February 5, 2016

Record last verified: 2016-01

Locations

CA (3)