ClinicalTrials.gg
CompletedNCT03414541Updated Jan 31, 2020

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

A Phase 2 interventional study of DS102 and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Afimmune. Completed at 3 sites in United Kingdom. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-31.

Sponsored by Afimmune · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2017, registered Jan 2018).
Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 620 studies in Pulmonary Disease, Chronic Obstructive with a site in United Kingdom — 60 open to participants now, 75 under way, 10 of them phase 3. Pulmonary Disease, Chronic Obstructive · United Kingdom.

Enrollment
295th of 465
49 · median 80
Started
2017
with 33 others
Phase 2
91 of 620
4 open now
Registered
407th of 620
by date

Among the 620 studies in Pulmonary Disease, Chronic Obstructive with a site in United Kingdom, this one is the 295th largest by enrollment of the 465 interventional ones that give a count, is one of 34 that started in 2017, is one of 91 in phase 2, and was the 407th registered.

Pulmonary Disease, Chronic Obstructive

5,521 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

60 of the 620 studies in Pulmonary Disease, Chronic Obstructive with a site in United Kingdom are open now. Recruiting first, the newest first:

55 more — sign in →

All 60 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 88 take healthy volunteers.

This study: 40 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study summary

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).

03

Conditions studied

  • Chronic Obstructive Pulmonary Disease
04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients (male or female) aged 40-75 years with stable 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 .

Exclusion criteria

Exclusion Criteria:

  • Patients with a history of 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 , 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 to any ingredients of the study treatment.
  • Patients, in the opinion of the Investigator, not suitable to participate in the study
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
49 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Participants in this group will receive matching placebo capsules twice daily.

    Other: Placebo

  • Experimental
    500mg DS102

    Participants in this group will receive 500 mg DS102 capsules twice daily.

    Drug: DS102

  • Experimental
    1000mg DS102

    Participants in this group will receive 1000 mg DS102 capsules twice daily.

    Drug: DS102

Interventions

  • DrugDS102

    DS102

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Change in induced sputum differential neutrophil count from baseline to Week 12

    Time frame: 12 weeks

  2. Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation.

    Time frame: 12 Weeks

Secondary outcomes

  1. Change in induced sputum neutrophil differential count from baseline

    Time frame: 14 weeks

  2. 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.

    Time frame: 14 weeks

07

Study locations

3 sites
  • UK Site 2
    Belfast, United Kingdom
  • UK Site 3
    London, United Kingdom
  • UK Site 1
    Manchester, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Jan 2019, 15 months.

Of 118 industry-sponsored phase 2 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 20. This study's 15 months is close to that.

Counting every sponsor, half of 165 studies reached it within 17 months; a quarter within 10 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2018
First posted
Jan 30, 2018
StartActual
Sep 24, 2017
Primary completionActual
Jan 11, 2019
CompletionActual
Jan 29, 2019
Last update
Jan 31, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03414541
Lead sponsor
Afimmune
Responsible party
Sponsor
First posted
Jan 30, 2018
Start date
Sep 24, 2017
Primary completion
Jan 11, 2019
Completion
Jan 29, 2019
Last update
Jan 31, 2020

Study contacts

Ian Pavord, MA DM FRCP FERS FMedSci
principal investigator · University of Oxford, Oxford, UK

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: DS102

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