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)

NCT04540042 | Completed Phase 2 FDA Drug

• 2 other identifiers: SELK2-000062020-001027-13
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease

Keywords

asthma; chronic obstructive pulmonary disease; COPD; adhesion molecule; P-selectin glycoprotein ligand 1; P-selectin

Outcome Measures

Primary Outcomes (2)

• 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 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).

  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

Study Arms (4)

SelK2 (Part 1)

EXPERIMENTAL

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

Drug: SelK2 (Part 1)

Placebo (Part 1)

PLACEBO COMPARATOR

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

Drug: Placebo (Part 1)

SelK2 (Part 2)

EXPERIMENTAL

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

Drug: SelK2 (Part 2)

Placebo (Part 2)

PLACEBO COMPARATOR

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

Drug: Placebo (Part 2)

Interventions

SelK2 (Part 1) DRUG

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

SelK2 (Part 1)

Placebo (Part 1) DRUG

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

Placebo (Part 1)

SelK2 (Part 2) DRUG

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

SelK2 (Part 2)

Placebo (Part 2) DRUG

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

Placebo (Part 2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• Tetherex Pharmaceuticals Corporation: lead

Study Sites (2)

Queen Anne Street Medical Centre

London, United Kingdom

Location

Medicines Evaluation Unit Ltd.

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Stocker, Ph.D.

  Tetherex Pharmaceuticals Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: August 18, 2020
• Primary Completion: December 21, 2021
• Study Completion: January 13, 2022
• Last Updated: February 2, 2022

Record last verified: 2022-02

Locations

GB (2)