Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease

A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase IIa Study To Assess The Safety And Efficacy Of Orally Administered DS102 In Chronic Obstructive Pulmonary Disease Patients

The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to assess the safety and efficacy of orally administered DS102 capsules versus placebo in the treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Placebo; Drug: DS102

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom
    • UK Site 2
  • London, United Kingdom
    • UK Site 3
  • Manchester, United Kingdom
    • UK Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients (male or female) aged 40-75 years with stable COPD at the time of screening.
• Patients who are current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack- years are defined as 20 cigarettes a Day for 10 years, or 10 cigarettes a Day for 20 years).
• Patients whose pre-study clinical laboratory findings do not interfere with their participation in the study, in the opinion of the Investigator.
• Patients who are able to communicate well with the Investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.

Exclusion Criteria:

• Patients with a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
• Patients with significant systemic or major illness other than pulmonary disease, including coronary artery disease, liver disease, cerebrovascular disease, renal insufficiency, serious psychiatric disease, respiratory or hypertensive disease, as well as diabetes and arthritis that, in the opinion of the Investigator, would preclude the patient from participating in and completing the study.
• Patients with known hypersensitivity to any ingredients of the study treatment.
• Patients, in the opinion of the Investigator, not suitable to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Participants in this group will receive matching placebo capsules twice daily.	Other: Placebo; Placebo
EXPERIMENTAL: 500mg DS102; Participants in this group will receive 500 mg DS102 capsules twice daily.	Drug: DS102; DS102
EXPERIMENTAL: 1000mg DS102; Participants in this group will receive 1000 mg DS102 capsules twice daily.	Drug: DS102; DS102

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in induced sputum differential neutrophil count from baseline to Week 12	12 weeks
Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation.	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in induced sputum neutrophil differential count from baseline		14 weeks
Change in St Georges Respiratory Questionnaire (SGRQ) from baseline	Questionnaire designed to measure impact of COPD on overall health, daily life and perceived well-being. Scores range from 0 -100 with higher scores indicating more limitations.	14 weeks

Collaborators and Investigators

• Sponsor: Afimmune
• Investigators: Principal Investigator: Ian Pavord, MA DM FRCP FERS FMedSci, University of Oxford, Oxford, UK

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 24, 2017
• Primary Completion (ACTUAL): January 11, 2019
• Study Completion (ACTUAL): January 29, 2019

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (ACTUAL): January 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: DS102A-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No