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 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)

Sponsors

Lead Sponsor: Tetherex Pharmaceuticals Corporation

Source Tetherex Pharmaceuticals Corporation
Brief 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 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.

Overall Status Recruiting
Start Date August 18, 2020
Completion Date February 21, 2021
Primary Completion Date January 31, 2021
Phase Phase 2
Study Type Interventional
Primary 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). 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). Change from baseline to Day 22
Secondary Outcome
Measure 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). 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) 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). 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) Pre-challenge to between 0 and 8 hours after the administration of allergen inhalation challenge
Change from baseline in pre-challenge FEV1 (Part 1). Change from baseline to Day 29
Change from baseline in percentage of neutrophils (Part 2). 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). Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in FEV1 and post-bronchodilator FEV1 (Part 2). Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in pre- and post-bronchodilator impulse oscillometry (IOS) (Part 2). Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in pre- and post-bronchodilator whole body plethysmography (Part 2). Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in COPD Assessment Test (CAT) scores (Part 2). Change from baseline to Days 4, 8, 15, 22, and 29
Change from baseline in Breathlessness Cough and Sputum Scale (BCSS) scores (Part 2). Change from baseline to Days 4, 8, 15, 22, and 29
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: SelK2 (Part 1)

Description: I.V., multiple-dose (Day 1 and Day 22)

Arm Group Label: SelK2 (Part 1)

Intervention Type: Drug

Intervention Name: Placebo (Part 1)

Description: I.V., multiple-dose (Day 1 and Day 22)

Arm Group Label: Placebo (Part 1)

Intervention Type: Drug

Intervention Name: SelK2 (Part 2)

Description: I.V., single-dose (Day 1)

Arm Group Label: SelK2 (Part 2)

Intervention Type: Drug

Intervention Name: Placebo (Part 2)

Description: I.V., single-dose (Day 1)

Arm Group Label: Placebo (Part 2)

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jonathan Stocker, Ph.D. Study Director Tetherex Pharmaceuticals Corporation
Overall Contact

Last Name: Jonathan Stocker, Ph.D.

Phone: 855-222-0722

Email: [email protected]

Location
Facility: Status:
Queen Anne Street Medical Centre | London, United Kingdom Recruiting
Medicines Evaluation Unit Ltd. | Manchester, United Kingdom Recruiting
Location Countries

United Kingdom

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: SelK2 (Part 1)

Type: Experimental

Description: I.V., multiple-dose (Day 1 and Day 22)

Label: Placebo (Part 1)

Type: Placebo Comparator

Description: I.V., multiple-dose (Day 1 and Day 22)

Label: SelK2 (Part 2)

Type: Experimental

Description: I.V., single-dose (Day 1)

Label: Placebo (Part 2)

Type: Placebo Comparator

Description: I.V., single-dose (Day 1)

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention 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.

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov