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

• Status: Completed
• Trial end date: 2018-10-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AnaptysBio, Inc.

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.