- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04540042
Study to Assess the Safety and Efficacy of SelK2 on Airway Responses Following Allergen Challenge in Subjects With Asthma (Part 1) and in Subjects With Chronic Obstructive Pulmonary Disease (Part 2)
February 1, 2022 updated by: Tetherex Pharmaceuticals Corporation
A Two Part, Randomised, Double-blind, Placebo-controlled, Phase 2 Parallel Group Study to Evaluate the Safety and Efficacy of Intravenously-Administered SelK2 on Airway Responses Following Allergen Challenge in Subjects With Asthma (Part 1) and to Evaluate the Safety and Efficacy of Intravenously-Administered SelK2 in Subjects With Chronic Obstructive Pulmonary Disease (Part 2)
This study has two parts.
The main purpose of Part 1 of this study will be to examine how safe and effective two doses of SelK2 is on participants with mild asthma.
Lung function and inflammatory cell numbers will be measured in response to the administration of an allergen (a compound to which the participant is allergic) into the lungs in the presence or absence of SelK2.
Part 2 of this study will examine how safe and effective one dose of SelK2 is on participants with chronic obstructive pulmonary disease (COPD).
Lung function and inflammatory cell numbers will be measured in COPD patients in the presence or absence of SelK2.
SelK2 may block the movement of key inflammatory cells into the lungs and consequently improve lung function in these two patient populations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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London, United Kingdom
- Queen Anne Street Medical Centre
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Manchester, United Kingdom
- Medicines Evaluation Unit Ltd.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Part 1:
Key Inclusion Criteria
- Males or females, 18-65 years of age (inclusive)
- Body Mass Index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2
- Documented physician-diagnosed asthma for ≥ 4 months prior to screening
- Pre-bronchodilator FEV1 ≥ 70% predicted at screening
- Documented allergy to at least one common allergen as confirmed by the skin prick test
- Dual responder to inhaled bronchial allergen challenges as manifested by positive allergen-induced early (EAR) and late airway bronchoconstriction (LAR) at screening
Key Exclusion Criteria
- Lung disease other than stable, mild asthma; e.g., worsening of asthma that requires a change in asthma therapy in the past 4 weeks or is deemed clinically significant by the investigator.
- A diagnosed current or recent (within previous 8 weeks of screening, or prior to randomisation) bacterial, protozoal, viral or parasitic infection; is suspected of or is at high risk of having a parasitic infection, or has a history of more than one episode of herpes zoster infection.
- Has a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest and/or hypoxic seizures.
- Has been hospitalised or has attended the emergency room for asthma in the 12 months prior to screening, or prior to randomisation.
- A history of tuberculosis (latent or active) or systemic fungal diseases.
Part 2:
Key Inclusion Criteria
- Male or female, 40 to 75 years of age, inclusive, at the time of informed consent.
- Confirmed diagnosis by a physician of COPD with symptoms compatible with COPD for at least 1 year prior to screening.
- BMI ≥ 18.0 and ≤ 35.0 kg/m2 at screening.
- Able to tolerate sputum induction and produce an adequate sputum sample with a neutrophil differential count > 55% at screening.
- Post-bronchodilator FEV1 ≥ 30% and ≤ 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at the time of Screening.
- Current or former tobacco smoker who has 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).
- Has a negative result in the blood test for tuberculosis (TB) at screening.
Key Exclusion Criteria
- COPD exacerbation requiring oral steroids and/or antibiotics, within the 8 weeks prior to screening or prior to randomisation.
- A positive sputum culture at Screening indicating ongoing infection.
- Other respiratory disorders: Subjects with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, known alpha-1 antitrypsin deficiency or other active pulmonary diseases other than COPD.
- A history of life-threatening COPD including intensive care unit admission and/or requiring intubation within the last 5 years.
- A history of > 1 hospitalisation for COPD in the previous 1 year prior to screening.
- Previous lung resection, lung reduction surgery or lung transplantation.
- Requires supplemental oxygen, even on an occasional basis.
- Any infection requiring hospitalisation or intravenous antibiotics within 6 months prior to Screening or prior to randomisation.
- A diagnosed current or recent (within previous 8 weeks of screening, or prior to randomisation) bacterial, protozoal, viral or parasitic infection; is suspected of or is at high risk of having a parasitic infection, or has a history of more than one episode of herpes zoster infection.
- Active participation in a pulmonary rehabilitation program.
- A history of tuberculosis (latent or active) or systemic fungal diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SelK2 (Part 1)
I.V., multiple-dose (Day 1 and Day 22)
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I.V., multiple-dose (Day 1 and Day 22)
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Placebo Comparator: Placebo (Part 1)
I.V., multiple-dose (Day 1 and Day 22)
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I.V., multiple-dose (Day 1 and Day 22)
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Experimental: SelK2 (Part 2)
I.V., single-dose (Day 1)
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I.V., single-dose (Day 1)
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Placebo Comparator: Placebo (Part 2)
I.V., single-dose (Day 1)
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I.V., single-dose (Day 1)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum percentage fall in FEV1 from pre-challenge between 3 and 8 hours (LAR) after administration of allergen inhalation challenge (Part 1).
Time Frame: Pre-challenge to between 3 and 8 hours after administration of allergen inhalation challenge
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Pre-challenge to between 3 and 8 hours after administration of allergen inhalation challenge
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Change from baseline in percentage of neutrophils in sputum (Part 2).
Time Frame: Change from baseline to Day 22
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Change from baseline to Day 22
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC for the percent fall in FEV1 from pre-challenge between 3 and 8 hours (LAR) after the administration of allergen inhalation challenge (Part 1).
Time Frame: Pre-challenge to between 3 and 8 hours after administration of allergen inhalation challenge
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Pre-challenge to between 3 and 8 hours after administration of allergen inhalation challenge
|
|
Change from baseline and change during challenge in percentage of eosinophils in sputum (Part 1)
Time Frame: Change from baseline to 8 and 24 hours post allergen challenge
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Change from baseline to 8 and 24 hours post allergen challenge
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|
Maximum percentage fall in FEV1 and AUC for the percent fall in FEV1 from pre-challenge between 0 and 2 hours after the administration of allergen inhalation challenge (EAR) (Part 1).
Time Frame: Pre-challenge to between 0 and 2 hours after the administration of allergen inhalation challenge
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Pre-challenge to between 0 and 2 hours after the administration of allergen inhalation challenge
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Maximum percentage fall in FEV1 and AUC for the percent fall in FEV1 between 0 and 8 hours (entire asthmatic response) after the administration of allergen inhalation challenge (Part 1)
Time Frame: Pre-challenge to between 0 and 8 hours after the administration of allergen inhalation challenge
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Pre-challenge to between 0 and 8 hours after the administration of allergen inhalation challenge
|
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Change from baseline in pre-challenge FEV1 (Part 1).
Time Frame: Change from baseline to Day 29
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Change from baseline to Day 29
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Change from baseline in percentage of neutrophils (Part 2).
Time Frame: Change from baseline to Days 4, 8, 15, and 29
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Change from baseline to Days 4, 8, 15, and 29
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Change from baseline in absolute and percentage cell counts for immune cells in induced sputum samples and blood (Part 2).
Time Frame: Change from baseline to Days 4, 8, 15, 22, and 29
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Change from baseline to Days 4, 8, 15, 22, and 29
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Change from baseline in FEV1 and post-bronchodilator FEV1 (Part 2).
Time Frame: Change from baseline to Days 4, 8, 15, 22, and 29
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Change from baseline to Days 4, 8, 15, 22, and 29
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Change from baseline in pre- and post-bronchodilator impulse oscillometry (IOS) (Part 2).
Time Frame: Change from baseline to Days 4, 8, 15, 22, and 29
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Change from baseline to Days 4, 8, 15, 22, and 29
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Change from baseline in pre- and post-bronchodilator whole body plethysmography (Part 2).
Time Frame: Change from baseline to Days 4, 8, 15, 22, and 29
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Change from baseline to Days 4, 8, 15, 22, and 29
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Change from baseline in COPD Assessment Test (CAT) scores (Part 2).
Time Frame: Change from baseline to Days 4, 8, 15, 22, and 29
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Scores range from 0-40 with 40 being associated with the worst outcome.
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Change from baseline to Days 4, 8, 15, 22, and 29
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Change from baseline in Breathlessness Cough and Sputum Scale (BCSS) scores (Part 2).
Time Frame: Change from baseline to Days 4, 8, 15, 22, and 29
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Scores range from 0-12 with 12 being associated with the worst outcome.
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Change from baseline to Days 4, 8, 15, 22, and 29
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jonathan Stocker, Ph.D., Tetherex Pharmaceuticals Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2020
Primary Completion (Actual)
December 21, 2021
Study Completion (Actual)
January 13, 2022
Study Registration Dates
First Submitted
August 31, 2020
First Submitted That Met QC Criteria
August 31, 2020
First Posted (Actual)
September 7, 2020
Study Record Updates
Last Update Posted (Actual)
February 2, 2022
Last Update Submitted That Met QC Criteria
February 1, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SELK2-00006
- 2020-001027-13 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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