AsthmaPhase 2NCT04540042
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)
A Phase 2 study testing SelK2 (Part 1) and SelK2 (Part 2) in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Tetherex Pharmaceuticals Corporation at 2 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- What is being tested?
- SelK2 (Part 1) and SelK2 (Part 2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 18 Aug 2020to 13 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Queen Anne Street Medical Centre
London
Medicines Evaluation Unit Ltd.
Manchester
About this study
Official title: 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.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Being tested
- SelK2 (Part 1), Placebo (Part 1), SelK2 (Part 2), Placebo (Part 2)
- Keywords
- asthma, chronic obstructive pulmonary disease, COPD, adhesion molecule, P-selectin glycoprotein ligand 1, P-selectin
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelK2 (Part 1)Drug
I.V., multiple-dose (Day 1 and Day 22)
Placebo (Part 1)Drug
I.V., multiple-dose (Day 1 and Day 22)
SelK2 (Part 2)Drug
I.V., single-dose (Day 1)
Placebo (Part 2)Drug
I.V., single-dose (Day 1)
| Study group | Role | What they receive |
|---|---|---|
| SelK2 (Part 1) | Experimental | I.V., multiple-dose (Day 1 and Day 22) Receives: Drug: SelK2 (Part 1) |
| Placebo (Part 1) | Placebo comparator | I.V., multiple-dose (Day 1 and Day 22) Receives: Drug: Placebo (Part 1) |
| SelK2 (Part 2) | Experimental | I.V., single-dose (Day 1) Receives: Drug: SelK2 (Part 2) |
| Placebo (Part 2) | Placebo comparator | I.V., single-dose (Day 1) Receives: Drug: Placebo (Part 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum percentage fall in FEV1 from pre-challenge between 3 and 8 hours (LAR) after administration of allergen inhalation challenge (Part 1).
Measured: Pre-challenge to between 3 and 8 hours after administration of allergen inhalation challenge
Change from baseline in percentage of neutrophils in sputum (Part 2).
Measured: Change from baseline to Day 22
Secondary outcomes (12)
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).
Measured: 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)
Measured: Change from baseline to 8 and 24 hours post allergen challenge
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).
Measured: Pre-challenge to between 0 and 2 hours after the administration of allergen inhalation challenge
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)
Measured: Pre-challenge to between 0 and 8 hours after the administration of allergen inhalation challenge
Change from baseline in pre-challenge FEV1 (Part 1).
Measured: Change from baseline to Day 29
Change from baseline in percentage of neutrophils (Part 2).
Measured: Change from baseline to Days 4, 8, 15, and 29
Change from baseline in absolute and percentage cell counts for immune cells in induced sputum samples and blood (Part 2).
Measured: Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in FEV1 and post-bronchodilator FEV1 (Part 2).
Measured: Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in pre- and post-bronchodilator impulse oscillometry (IOS) (Part 2).
Measured: Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in pre- and post-bronchodilator whole body plethysmography (Part 2).
Measured: Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in COPD Assessment Test (CAT) scores (Part 2).
Scores range from 0-40 with 40 being associated with the worst outcome.
Measured: Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in Breathlessness Cough and Sputum Scale (BCSS) scores (Part 2).
Scores range from 0-12 with 12 being associated with the worst outcome.
Measured: Change from baseline to Days 4, 8, 15, 22, and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start18 Aug 2020
- Primary completion21 Dec 2021
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 of the study will enroll patients in two arms in a 1:1 ratio to receive either SelK2 or placebo. Part 2 of the study will enroll patients in two arms in a 2:1 ratio to receive either SelK2 or placebo, respectively.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetherex Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Stocker, Ph.D., Study director, Tetherex Pharmaceuticals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540042
- Sponsor's protocol ID
- SELK2-00006
- Other IDs
- 2020-001027-13
- Status last verified
- Feb 2022
- First submitted
- 31 Aug 2020
- Last updated
- 2 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04540042
- Acronym / sponsor ID
- SELK2-00006
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Keywords
- asthma, chronic obstructive pulmonary disease, COPD, adhesion molecule, P-selectin glycoprotein ligand 1, P-selectin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Tetherex Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Part 1 of the study will enroll patients in two arms in a 1:1 ratio to receive either SelK2 or placebo. Part 2 of the study will enroll patients in two arms in a 2:1 ratio to receive either SelK2 or placebo, respectively.
| Arm | Type | Receives |
|---|---|---|
| SelK2 (Part 1) | Experimental | Drug: SelK2 (Part 1)I.V., multiple-dose (Day 1 and Day 22) |
| Placebo (Part 1) | Placebo comparator | Drug: Placebo (Part 1)I.V., multiple-dose (Day 1 and Day 22) |
| SelK2 (Part 2) | Experimental | Drug: SelK2 (Part 2)I.V., single-dose (Day 1) |
| Placebo (Part 2) | Placebo comparator | Drug: Placebo (Part 2)I.V., single-dose (Day 1) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelK2 (Part 1)I.V., multiple-dose (Day 1 and Day 22) | Drug | SelK2 (Part 1) |
| Placebo (Part 1)I.V., multiple-dose (Day 1 and Day 22) | Drug | Placebo (Part 1) |
| SelK2 (Part 2)I.V., single-dose (Day 1) | Drug | SelK2 (Part 2) |
| Placebo (Part 2)I.V., single-dose (Day 1) | Drug | Placebo (Part 2) |
Primary outcome
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
Change from baseline in percentage of neutrophils in sputum (Part 2).
Time frame: Change from baseline to Day 22
12 secondary outcomes
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
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
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
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
Change from baseline in pre-challenge FEV1 (Part 1).
Time frame: Change from baseline to Day 29
Change from baseline in percentage of neutrophils (Part 2).
Time frame: Change from baseline to Days 4, 8, 15, and 29
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
Change from baseline in FEV1 and post-bronchodilator FEV1 (Part 2).
Time frame: Change from baseline to Days 4, 8, 15, 22, and 29
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
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
Change from baseline in COPD Assessment Test (CAT) scores (Part 2).
Time frame: Change from baseline to Days 4, 8, 15, 22, and 29
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Stocker, Ph.D. study director
Tetherex Pharmaceuticals Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SelK2 (Part 1) and SelK2 (Part 2) in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Tetherex Pharmaceuticals Corporation at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.