A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma

NCT ID: NCT04007198

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-20
• Study Completion Date: 2021-10-12

Brief Summary

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with moderate-to-severe asthma.

Detailed Description

The study will enroll up to 40 subjects, with up to 5 dose escalating cohorts of 8 patients enrolled in a 3:1 ratio. Subjects will receive either itolizumab or placebo administered subcutaneously every two weeks (over 8 weeks) for a total of 5 doses with 4 weeks of follow-up.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EQ001

EQ001 administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.

Group Type: EXPERIMENTAL

EQ001

Intervention Type: DRUG

Itolizumab \[Bmab 600\]

EQ001 Placebo

Placebo administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.

Group Type: PLACEBO_COMPARATOR

EQ001 Placebo

Intervention Type: DRUG

EQ001 Placebo

Interventions

EQ001

Itolizumab \[Bmab 600\]

Intervention Type: DRUG

EQ001 Placebo

EQ001 Placebo

Intervention Type: DRUG

Other Intervention Names

Bmab600; Itolizumab

Eligibility Criteria

Inclusion Criteria

1. Is male or female, age ≥ 18 and ≤ 75 years

2. Has a documented clinical diagnosis of moderate-to-severe uncontrolled asthma requiring moderate- or high-dose inhaled CS (ICS; ≥ 250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) and one or more additional controller medications (inhaled LABA or anticholinergic or LTA) for ≥ 3 months, with a stable dose ≥1 month prior to the initial Screening Visit

3. Has a prebronchodilator forced expiratory volume in 1 second (FEV1) ≥ 40% and ≤ 90% of predicted value during the Screening Period, despite use of a moderate- or high-dose ICS and one or more additional controller medications (inhaled LABA or anticholinergic or LTA)

4. Has a history of clinically diagnosed asthma, which could include a history of FEV1 reversibility and/or positive bronchial challenge test

5. Has a history of ≥ 1 clinically significant asthma exacerbation prior to the initial Screening Visit, despite use of a moderate- or high dose ICS and one or more additional controller medications at the time the exacerbation(s) occurred

Exclusion Criteria

1. Is a current or former smoker with a smoking history of ≥10 pack-years (number of pack-years = number of cigarettes per day/20 × number of years smoked; a former smoker is defined as a subject who stopped smoking ≥ 6 months prior to the Screening Visit)

2. Has a body mass index > 36 kg/m2

3. Has a documented history or radiological evidence of a clinically important lung condition other than asthma (eg, α1 antitrypsin deficiency, bronchiectasis, cystic fibrosis, primary ciliary dyskinesia, pulmonary fibrosis, allergic bronchopulmonary mycosis, or lung cancer)

4. Has a respiratory tract infection (RTI) within 4 weeks before the initial Screening Visit, or during the Screening Period (these subjects may be re-screened following complete resolution of their RTI)

5. Has an asthma exacerbation within 4 weeks before the initial Screening Visit, or during the Screening Period (these subjects may be re-screened following complete resolution of their exacerbation)

6. Has a diagnosis of currently active malignancy; subjects with a medical history of basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the uterine cervix are eligible; subjects with a medical history of other malignancies are eligible if the subject is in remission and curative therapy was completed ≥ 2 years prior to the initial Screening Visit

7. Has a history or presence of clinically concerning cardiac arrythmias, atrial fibrillation, New York Heart Association Class III or IV heart failure, or prolonged QT or corrected QT interval > 500 milliseconds (ms) at the Screening Visit

8. Has any disorder (including, but not limited to, cardiovascular [CV], gastrointestinal [GI], hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment) that is not stable in the opinion of the investigator and/or could:

1. Affect the subject's safety

2. Influence the findings of the study or data interpretation

3. Impede the subject's ability to complete the study

9. Has undergone bronchial thermoplasty

10. Has a history of substance abuse (including alcohol) that may, in the investigator's judgment, increase the risk to the subject of participation in the study

11. Has used monoclonal antibody (mAb) therapy for the management of asthma or any other condition within 3 months prior to the initial Screening Visit (these subjects may be re-screened following the 3 month period)

12. Has required an oral corticosteroid burst within 1 month prior to the initial Screening Visit or during the Screening Period (these subjects may be re-screened following the 1 month period); maintenance oral corticosteroids ≤ 10 mg/d prednisone or equivalent is permitted

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocon Limited

INDUSTRY

Sponsor Role: collaborator

Equillium AUS Pty Ltd

UNKNOWN

Sponsor Role: collaborator

Equillium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jo A Douglass, MD

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

Flinders Medical Centre

Adelaide, , Australia

Box Hill Hospital

Box Hill, , Australia

Monash Medical Centre

Clayton, , Australia

Paratus Clinical Research Central Coast

Kanwal, , Australia

Respiratory Clinical Trials

Kent Town, , Australia

TrialsWest

Murdoch, , Australia

Melbourne Health

Parkville, , Australia

Paratus Clinical Research Western Sydney

Sydney, , Australia

The Queen Elizabeth Hospital

Woodville, , Australia

Respiratory Research, Greenland Clinical Centre

Auckland, , New Zealand

Dunedin Hospital

Dunedin, , New Zealand

The New Zealand Respiratory & Sleep Institute

Greenlane, , New Zealand

Medical Research Institute of New Zealand

Wellington, , New Zealand

Countries

Australia; New Zealand

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://equilliumbio.com/

company website

http://www.anzctr.org.au/

Australia New Zealand Clinical Trials Registry

Other Identifiers

EQ001-19-001

Identifier Type: -

Identifier Source: org_study_id