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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03469934
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
AnaptysBio, Inc.

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
Eosinophilic Asthma Drug: ANB020 Drug: Placebo 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 Type : Interventional  (Clinical Trial)
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 : November 14, 2017
Actual Primary Completion Date : October 29, 2018
Actual Study Completion Date : October 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: ANB020
ANB020, administration of ANB020
Drug: ANB020
ANB020

Placebo Comparator: Placebo
Placebo, administration of Placebo
Drug: Placebo
Placebo




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 [ Time Frame: 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 [ Time Frame: Through study completion, Day 127 ]
    Monitor peripheral blood eosinophil counts


Secondary Outcome Measures :
  1. Change in respiratory assessments [ Time Frame: Through study completion, Day 127 ]
    Monitor FEV1 variation

  2. Describe Limited Pharmacokinetics: Cmax [ Time Frame: Throughout study, Day 64 ]
    Maximum observed concentration (Cmax)

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

  4. Test for immunogenicity [ Time Frame: Through study completion, Day 127 ]
    Detection of ADA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469934


Locations
United States, Illinois
Midwest Allergy Sinus Asthma
Normal, Illinois, United States, 61761
United States, Michigan
Pulmonary & Critical Care Specialists
Novi, Michigan, United States, 48375
United States, Oklahoma
OK Clinical Research, LLC
Edmond, Oklahoma, United States, 73034
United States, Oregon
Allergy & Asthma Center of Southern Oregon
Medford, Oregon, United States, 97504
United Kingdom
Medicines Evaluation Unit
Manchester, Greater Manchester, United Kingdom, M239Q
Glenfield Hospital
Leicester, Leicestershire, United Kingdom, LE3 9QP
Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Sponsors and Collaborators
AnaptysBio, Inc.
Investigators
Study Director: Marco Londei, M.D. AnaptysBio, Inc.

Responsible Party: AnaptysBio, Inc.
ClinicalTrials.gov Identifier: NCT03469934     History of Changes
Other Study ID Numbers: ANB020-004
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
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
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases