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Proof of Concept Study to Investigate ANB020 Activity in Adult Patients With Severe Eosinophilic Asthma

Sponsor
AnaptysBio, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03469934
Collaborator
(none)
25
Enrollment
7
Locations
2
Arms
11.5
Actual Duration (Months)
3.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study will also assess the safety and tolerability of ANB020 in adult patients with severe eosinophilic asthma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a multi-center, randomized, double-blind, placebo-controlled, proof of concept study to assess the safety and tolerability of ANB20 in adult patients with severe eosinophilic asthma.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Placebo Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients With Severe Eosinophilic Asthma
Actual Study Start Date :
Nov 14, 2017
Actual Primary Completion Date :
Oct 29, 2018
Actual Study Completion Date :
Oct 29, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: ANB020

ANB020, administration of ANB020

Drug: ANB020
ANB020
Placebo Comparator: Placebo

Placebo, administration of Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Safety of ANB020 in adult patients with severe eosinophilic asthma: Number of participants with treatment-related adverse events as assessed by CTCAE v. 4.0 [Through study completion, Day 127]

    Number of participants with treatment-related adverse events as assessed by CTCAE v. 4.0

  2. Change in blood eosinophil count [Through study completion, Day 127]

    Monitor peripheral blood eosinophil counts

Secondary Outcome Measures

  1. Change in respiratory assessments [Through study completion, Day 127]

    Monitor FEV1 variation

  2. Describe Limited Pharmacokinetics: Cmax [Throughout study, Day 64]

    Maximum observed concentration (Cmax)

  3. Describe Limited Pharmacokinetics: Time to Cmax [Throughout study, Day 64]

    Time to Cmax

  4. Test for immunogenicity [Through study completion, Day 127]

    Detection of ADA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male and female patients aged ≥18 to ≤65 years and able to give informed consent.

  • Patients with a confirmed clinical diagnosis of eosinophilic asthma

  • History of diagnosis of eosinophilic asthma

  • Severe asthma diagnosed according to the Global Initiative for Asthma (GINA) 2016

  • Body mass index (BMI) of 18 to 38 kg/m2 (inclusive) and total body weight >50 kg (110 lb.).

  • Women of childbearing potential must have a negative serum pregnancy test at screening and be willing to use effective methods of contraception throughout the study.

  • Male patients must be willing to use effective methods of contraception during the entire study period.

  • Patient must be on high dose ICS plus LABA.

  • Willing and able to comply with the study protocol requirements.

  • Have the ability to read and understand the study procedures and can communicate meaningfully with the Investigator and staff.

Exclusion Criteria:

  • Have concomitant medical condition(s) which may interfere with the Investigator's ability to evaluate the patient's response to the IP.

  • Have experienced severe life threatening anaphylactic reactions.

  • Have received any IP within a period of 3 months or 5 half lives of an IP

  • Have received high dose systemic corticosteroids

  • Have received treatment with biologics within 3 months or 5 half lives (whichever is longer) before screening.

  • Abnormal ECG assessment at screening

  • Uncontrolled hypertension, or acute ischemic cardiovascular diseases.

  • If female, is pregnant or lactating, or intend to become pregnant during the study period.

  • History (or suspected history) of alcohol or substance abuse within 2 years before screening.

  • Any comorbidity that the Investigator believes is a contraindication to study participation.

  • Have any other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments.

  • Planned surgery during the study or 30 days before screening.

  • History of malignancy within 5 years, except non melanoma skin cancer which has been fully treated with no current active disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Midwest Allergy Sinus Asthma Normal Illinois United States 61761
2 Pulmonary & Critical Care Specialists Novi Michigan United States 48375
3 OK Clinical Research, LLC Edmond Oklahoma United States 73034
4 Allergy & Asthma Center of Southern Oregon Medford Oregon United States 97504
5 Medicines Evaluation Unit Manchester Greater Manchester United Kingdom M239Q
6 Glenfield Hospital Leicester Leicestershire United Kingdom LE3 9QP
7 Churchill Hospital Oxford Oxfordshire United Kingdom OX3 7LE

Sponsors and Collaborators

  • AnaptysBio, Inc.

Investigators

  • Study Director: Marco Londei, M.D., AnaptysBio, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AnaptysBio, Inc.
ClinicalTrials.gov Identifier:
NCT03469934
Other Study ID Numbers:
  • ANB020-004
First Posted:
Mar 19, 2018
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Asthma
Pulmonary Eosinophilia

Study Results

No Results Posted as of Sep 28, 2021