The Effect of FP-025, on Allergen-induced Airway Responses in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma.

NCT03858686 | Completed Phase 2 Results FDA Drug

• 1 other identifier: FP02C-18-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a Phase IIa, randomized, placebo-controlled, double-blind, 2-way crossover, 2-center (conducted in EU; The Netherlands) study in male and female subjects with stable, mild HDM-allergic asthma.

Conditions

Asthma, COPD

Outcome Measures

Primary Outcomes (1)

• Effect of FP-025 Versus Placebo on the Allergen (HDM)-Induced Late Asthmatic Response (LAR) in Subjects With Clinically Stable, Mild Allergic Asthma and Blood Eosinophilia.

  Late asthmatic response (LAR) is defined as FEV1 AUC3-8h; differences between FP025 and placebo in subjects with clinically stable, mild allergic asthma and blood eosinophilia.

  FEV1 measured hourly from 3 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate LAR(AUC3-8h)

Secondary Outcomes (14)

• Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Late Asthmatic Response (LAR)

  FEV1 measured hourly from 3 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate LAR(AUC3-8h)

• Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in EAR.

  FEV1 measured hourly from 0 to 3 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate EAR(AUC0-3h)

• Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Early Asthmatic Response (EAR).

  FEV1 measured hourly from 0 to 3 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate maximal% fall in FEV1(0-3h)

• Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Joint HDM-induced Airway Response.

  FEV1 measured hourly from 0 to 8 hours post dose on Day 11 During Placebo and FP-025 in Subjects with HDM-Allergic Mild Asthma with Blood Eosinophilia to generate FEV1(AUC0-8h)

• Pharmacodynamic Endpoints Include the Effect of Study Treatments on Allergen (HDM)-Induced Changes in Airway Hyper-responsiveness

  PC20FEV1(Meth) or PC20FEV1(Hist) measured pre and post allergen (Day 10 versus Day12 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma

Other Outcomes (2)

• To Determine the Treatment Effect (FP-025 Versus Placebo) on Baseline Parameters (i.e. Day 1 Versus Day 10) , Through Measurement of Fractionated Nitric Oxide (FeNO).

  FeNO measured pre allergen (Day 1 versus Day10 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma

• To Determine the Treatment Effect (FP-025 Versus Placebo) on Baseline Parameters (i.e. Day 10 Versus Day 12), Through Measurement of Fractionated Nitric Oxide (FeNO).

  FeNO measured pre and post allergen (Day 10 versus Day12 in period 1 and period 2) in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma

Study Arms (2)

400 mg FP-025 capsules

ACTIVE COMPARATOR

Based on a double-blind randomized schedule, 16 subjects will receive FP-025 capsules in Period 1 and matching placebo FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.

Drug: FP-025 capsules; Drug: Placebo FP-025 capsules

FP-025 Placebo Capsules

PLACEBO COMPARATOR

Based on a double-blind randomized schedule, 16 subjects will receive matching placebo FP-025 capsules in Period 1 and FP-025 capsules in Period 2. Both study periods will follow the same schedule of procedures, with a washout period of at least 3 weeks and up to 7 weeks between study periods.

Drug: FP-025 capsules; Drug: Placebo FP-025 capsules

Interventions

FP-025 capsules DRUG

FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.

Also known as: Adermastat

400 mg FP-025 capsules; FP-025 Placebo Capsules

Placebo FP-025 capsules DRUG

Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.

Also known as: Placebo

400 mg FP-025 capsules; FP-025 Placebo Capsules

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The following criteria must be met by all subjects considered for study participation:
• Females or males, between 18 and 55 years of age at Screening, inclusive, on the day of signing the Informed Consent Form (ICF).
• Apart from a clinically stable asthma and HDM-allergy, subjects should be generally healthy with no history of a clinically relevant medical condition that in the opinion of the investigator might interfere with successful study conduct and no clinically relevant abnormalities on medical history, physical exam, vital signs, laboratory parameters or ECG at Screening.
• Subject has a BMI ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 (and weighs ≥50 kg).
• Subjects have been diagnosed with asthma cf GINA guidelines.
• Subjects should have established allergy for HDM (serum HDM-specific IgE or positive SPT at Screening or documented within 1 year pre-screening).
• No severe exacerbation of asthma within past 1 year requiring hospital admission and/or treatment with oral corticosteroids; no (never) intensive care admissions for asthma or intubation).
• FEV1 should be ≥70% of predicted on Screening Day 2.
• On Screening Day 2, PC20FEV1(Meth) should be \<16 mg/mL if methacholine chloride is used (or adjusted by a factor of 1.2 if methacholine bromide is used).
• Baseline blood eosinophils should be ≥150 cells/μL at Screening or documented within 3 months before Screening Day 1.
• Subjects should have a documented airway late response to inhaled HDM on Screening Day 3.
• Subjects of childbearing potential must be willing to use adequate contraception (double-barrier) or must refrain from intercourse.
• Female subjects of non-childbearing potential must have had
• ≥ 12 months of spontaneous amenorrhea (with folliclestimulating hormone \[FSH\] ≥ 30 mIU/mL). Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy (for 'benign' reasons), or bilateral tubal ligation.
• All female subjects should have a negative pregnancy test at Screening and on Day -1.

You may not qualify if:

• Subjects will be excluded if they meet any of the following criteria:
• Subject has any active and/or chronic (physical or mental) condition requiring maintenance (pharmaco)therapy or which otherwise precludes subject from safe or adequate study participation (ineligibility will be assessed by the PI).
• Subject has a history of cancer (exception: localized basalioma or cervix carcinoma in situ).
• Subject had any major (nasal) surgery in the 6 months before Screening Day 1.
• Subject is pregnant or lactating.
• Subject is using immunotherapy that according to the PI may interfere with the study (e.g. in case of immunotherapy with HDM or when subject is in the updosing phase of any immunotherapy).
• Subject regularly used alcohol (intake of \>21 units/wk for males and \>14 units/wk for females) and/or recreational drugs within the last 6 months prior to screening.
• Subject had any respiratory (viral) infections (e.g. common cold) within 3 weeks of Screening Day 1 or on Day -1.
• Subject is using maintenance asthma therapy or long-acting bronchodilators or any other anti-asthma or anti-allergic medications (as detailed in the protocol) other than infrequent use of SABA prn only.
• Subject is using prohibited medications as detailed in the protocol.
• Multi-sensitized symptomatic subjects with seasonal (pollen) allergies should be included outside of the relevant allergen season and/or should not be in frequent contact with the relevant allergen during the study.
• Subject has any known allergic response for the medications used or known severe allergic reactions or anaphylaxis (to food/medications/insect venoms).
• Subject participated in medical studies in the past 3 months (non-biologicals) or in the past 6 months (biologicals).
• Subject is anticipated not to comply with study medication or other aspects of the study (at the discretion of the investigator).

Sponsors & Collaborators

• Foresee Pharmaceuticals Co., Ltd.: lead

Study Sites (2)

Academic Medical Centre/University of Amsterdam, Department of Respiratory Medicine and Experiment Immunology

Amsterdam, 1105 AZ, Netherlands

Location

QPS Netherlands - Clinical Pharmacology Unit

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

FP-025

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

Results Point of Contact

• Title: Yisheng Lee, MD, Chief Medical Officer
• Organization: Foresee Pharmaceuticals

yisheng.lee@foreseepharma.com

4088234807

Study Officials

• Zuzana Diamant, MD, PhD

  QPS Netherlands

  PRINCIPAL INVESTIGATOR

• Rene Lutter

  Academic Medical Centre/University of Amsterdam

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: March 1, 2019
• Study Start: July 2, 2018
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)