NCT01954628: FLAGSHIP

The FLAGSHIP Study: A 12-week Phase II Study to Evaluate the Efficacy and Safety of AQX-1125 Following Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD) by Targeting the SHIP1 Pathway

Completed Phase 2 Results posted Last updated 8 May 2017

What this trial tests

Phase 2 trial testing AQX-1125 in COPD in 400 participants. Completed in 1 December 2015.

Timeline

1 October 2013

Primary endpoint
1 July 2015

1 December 2015

Quick facts

Lead sponsor	Aquinox Pharmaceuticals (Canada) Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	400
Start date	1 October 2013
Primary completion	1 July 2015
Estimated completion	1 December 2015
Sites	8 locations across United States, Australia, Denmark, Finland, Hungary, New Zealand, Poland, Sweden

Drugs / interventions tested

• AQX-1125 — full drug profile →
• Placebo

Conditions studied

• COPD — all drugs for COPD →

Sponsor

Aquinox Pharmaceuticals (Canada) Inc. — full company profile →

Who can join

40 and older, any sex, with COPD. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period.
  Time frame: 12 weeks
  The primary variable (endpoint) of this study is the difference in the Area Above the Curve (AAC) for the daily EXACT score from baseline to Week 12 between subjects treated with AQX-1125 and placebo.The EXACT questionnaire is a patient reported outcome (PRO) measure designed to standardise the method for evaluating the frequency, severity and duration of acute exacerbations of COPD. The EXACT is

Sponsor's own description

The primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of AQX-1125 compared to placebo in subjects following exacerbations of Chronic Obstructive Pulmonary Disease (COPD) by targeting the SHIP1 (Src Homology 2-containing Inositol-5'-Phosphatase 1) pathway.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PI3K inhibitors in inflammation, autoimmunity and cancer.
   Stark AK, Sriskantharajah S, Hessel EM, Hessel EM, et al · · 2015 · cited 236× · PMID 26093105 · DOI 10.1016/j.coph.2015.05.017
2. MicroRNA-155-at the Critical Interface of Innate and Adaptive Immunity in Arthritis.
   Alivernini S, Gremese E, McSharry C, Tolusso B, et al · · 2017 · cited 159× · PMID 29354135 · DOI 10.3389/fimmu.2017.01932
3. Novel approaches to the management of noneosinophilic asthma.
   Thomson NC. · · 2016 · cited 82× · PMID 26929306 · DOI 10.1177/1753465816632638
4. Phosphoinositide 3-Kinase in Asthma: Novel Roles and Therapeutic Approaches.
   Yoo EJ, Ojiaku CA, Sunder K, Panettieri RA. · · 2017 · cited 60× · PMID 27977296 · DOI 10.1165/rcmb.2016-0308tr
5. Driving chronicity in rheumatoid arthritis: perpetuating role of myeloid cells.
   Alivernini S, Tolusso B, Ferraccioli G, Gremese E, et al · · 2018 · cited 35× · PMID 29315512 · DOI 10.1111/cei.13098
6. The Mechanisms and Therapeutic Implications of PI3K Signaling in Airway Inflammation and Remodeling in Asthma.
   Song B, Hu J, Chen S, Zhang Y. · · 2025 · cited 3× · PMID 40070559 · DOI 10.2147/btt.s497622
7. The COPD Pipeline XXVII.
   Gross N. · · 2015 · cited 1× · PMID 28848841 · DOI 10.15326/jcopdf.2.2.2015.0137
8. Novel Immunomodulatory Therapies for Respiratory Pathologies
   Tavares L, Galvão I, Ferrero M. · · 2022