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

NCT04007198 | Completed Phase 1 Results DMC

• 1 other identifier: EQ001-19-001
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 13

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.

Conditions

Asthma

Keywords

moderate-to-severe asthma

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Emergent Adverse Events

  Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  Study Day 85

Secondary Outcomes (8)

• Time to Maximum EQ001serum Concentration, Tmax

  Study Day 85

• Maximum EQ001 Serum Drug Concentration, Cmax

  Study Day 85

• Minimum EQ001 Serum Drug Concentration, Cmin

  Study Day 85

• Total EQ001 Exposure Across Time, AUC (From Zero to Infinity)

  Study Day 85

• Volume of Distribution of EQ001, Vd

  Study Day 85

Study Arms (2)

EQ001

EXPERIMENTAL

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

Drug: EQ001

EQ001 Placebo

PLACEBO COMPARATOR

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

Drug: EQ001 Placebo

Interventions

EQ001 DRUG

Itolizumab \[Bmab 600\]

Also known as: Bmab600, Itolizumab

EQ001

EQ001 Placebo DRUG

EQ001 Placebo

EQ001 Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is male or female, age ≥ 18 and ≤ 75 years
• 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
• 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)
• Has a history of clinically diagnosed asthma, which could include a history of FEV1 reversibility and/or positive bronchial challenge test
• 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

You may not qualify if:

• 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)
• Has a body mass index \> 36 kg/m2
• 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)
• 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)
• 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)
• 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
• 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
• 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:
• Affect the subject's safety
• Influence the findings of the study or data interpretation
• Impede the subject's ability to complete the study
• Has undergone bronchial thermoplasty
• 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
• 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)
• 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

Sponsors & Collaborators

• Equillium: lead
• Biocon Limited: collaborator
• Equillium AUS Pty Ltd: collaborator

Study Sites (13)

Flinders Medical Centre

Adelaide, Australia

Location

Box Hill Hospital

Box Hill, Australia

Location

Monash Medical Centre

Clayton, Australia

Location

Paratus Clinical Research Central Coast

Kanwal, Australia

Location

Respiratory Clinical Trials

Kent Town, Australia

Location

TrialsWest

Murdoch, Australia

Location

Melbourne Health

Parkville, Australia

Location

Paratus Clinical Research Western Sydney

Sydney, Australia

Location

The Queen Elizabeth Hospital

Woodville, Australia

Location

Respiratory Research, Greenland Clinical Centre

Auckland, New Zealand

Location

Dunedin Hospital

Dunedin, New Zealand

Location

The New Zealand Respiratory & Sleep Institute

Greenlane, New Zealand

Location

Medical Research Institute of New Zealand

Wellington, New Zealand

Location

Related Links

• company website
• Australia New Zealand Clinical Trials Registry

MeSH Terms

Conditions

Asthma

Interventions

itolizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Operations
• Organization: Equillium

clinicaltrials@equilliumbio.com

8582401200

Study Officials

• Jo A Douglass, MD

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study site, participant and most vendors will be blinded. The site's pharmacist or designee will be unblinded to prepare the study drug. Relevant vendors including PK will be unblinded.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: up to 5 cohorts of 8 patients randomized 3:1 with ascending doses

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 5, 2019
• Study Start: June 20, 2019
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (4); AU (9)