A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma (EQUIP)
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ClinicalTrials.gov Identifier: NCT04007198 |
Recruitment Status :
Recruiting
First Posted : July 5, 2019
Last Update Posted : February 21, 2021
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Condition or disease | Intervention/treatment | Phase |
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Asthma | Drug: EQ001 Drug: EQ001 Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | up to 5 cohorts of 8 patients randomized 3:1 with ascending doses |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of EQ001 in Subjects With Moderate-to-Severe Uncontrolled Asthma |
Actual Study Start Date : | June 20, 2019 |
Estimated Primary Completion Date : | August 2021 |
Estimated Study Completion Date : | October 2021 |
Arm | Intervention/treatment |
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Experimental: EQ001
EQ001 administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.
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Drug: EQ001
Itolizumab [Bmab 600]
Other Names:
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Placebo Comparator: EQ001 Placebo
Placebo administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.
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Drug: EQ001 Placebo
EQ001 Placebo |
- Incidence of Treatment Emergent Adverse Events [ Time Frame: Study Day 85 ]Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- Time to maximum EQ001serum concentration, Tmax [ Time Frame: Study Day 85 ]Time to maximum EQ001 serum concentration, Tmax
- Maximum EQ001 serum drug concentration, Cmax [ Time Frame: Study Day 85 ]Maximum EQ001 serum drug concentration, Cmax
- Minimum EQ001 serum drug concentration, Cmin [ Time Frame: Study Day 85 ]Minimum EQ001 serum drug concentration prior to next dose, Cmin
- Total EQ001 exposure across time, AUC (from zero to infinity) [ Time Frame: Study Day 85 ]Total EQ001 exposure across time, AUC (from zero to infinity)
- Volume of distribution of EQ001, Vd [ Time Frame: Study Day 85 ]Volume of distribution of EQ001, Vd
- Clearance, Cl [ Time Frame: Study Day 85 ]Clearance, Cl
- Inflammatory Markers [ Time Frame: Study Day 85 ]Including but not limited to: IL-1β, IL-2, IL-6, IL-17, IL-21, IL-22, IL-23, IFN-γ, and TGF-β, C-reactive protein
- CD6 receptor expression [ Time Frame: Study Day 85 ]the % levels of free versus EQ001-bound CD6 receptor on T cells

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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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

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): NCT04007198
Contact: Dolca Thomas, MD | 858 412 5302 | clinicaltrials@equilliumbio.com |
Australia | |
Flinders Medical Centre | Recruiting |
Adelaide, Australia | |
Box Hill Hospital | Recruiting |
Box Hill, Australia | |
Monash Medical Centre | Recruiting |
Clayton, Australia | |
Paratus Clinical Research Central Coast | Recruiting |
Kanwal, Australia | |
Respiratory Clinical Trials | Recruiting |
Kent Town, Australia | |
TrialsWest | Recruiting |
Murdoch, Australia | |
Melbourne Health | Recruiting |
Parkville, Australia | |
Paratus Clinical Research Western Sydney | Recruiting |
Sydney, Australia | |
The Queen Elizabeth Hospital | Recruiting |
Woodville, Australia | |
New Zealand | |
Respiratory Research, Greenland Clinical Centre | Recruiting |
Auckland, New Zealand | |
Dunedin Hospital | Recruiting |
Dunedin, New Zealand | |
The New Zealand Respiratory & Sleep Institute | Recruiting |
Greenlane, New Zealand | |
Medical Research Institute of New Zealand | Recruiting |
Wellington, New Zealand |
Principal Investigator: | Jo A Douglass, MD | Melbourne Health |
Responsible Party: | Equillium |
ClinicalTrials.gov Identifier: | NCT04007198 |
Other Study ID Numbers: |
EQ001-19-001 |
First Posted: | July 5, 2019 Key Record Dates |
Last Update Posted: | February 21, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
moderate-to-severe asthma |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |