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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 : January 13, 2020
Sponsor:
Collaborator:
Biocon Limited
Information provided by (Responsible Party):
Equillium

Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE June 20, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2020)
  • 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 occupancy [ Time Frame: Study Day 85 ]
    the % levels of free versus EQ001-bound CD6 receptor on T cells
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • 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)
  • Half life of EQ001, t1/2 [ Time Frame: Study Day 85 ]
    Half life of EQ001, t1/2
  • 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 occupancy [ Time Frame: Study Day 85 ]
    the % levels of free versus EQ001-bound CD6 receptor on T cells
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: EQ001
    Itolizumab [Bmab 600]
    Other Names:
    • Bmab600
    • Itolizumab
  • Drug: EQ001 Placebo
    EQ001 Placebo
Study Arms  ICMJE
  • Experimental: EQ001
    EQ001 administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.
    Intervention: Drug: EQ001
  • 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.
    Intervention: Drug: EQ001 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 FEV1 reversibility of > 12% (% predicted increase) AND ≥ 200 mL (absolute increase) after administration of a short-acting beta agonist (200 to 400 mcg albuterol/salbutamol or equivalent) during the Screening Period or documented within the prior 2 years, or has a history of positive bronchial challenge test within the prior 2 years
  5. Has a history of ≥ 1 clinically significant asthma exacerbation (see definition in Section 9.2.2) in the 12 months 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephanie Leyva 858 412 5302 clinicaltrials@equilliumbio.com
Listed Location Countries  ICMJE Australia,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007198
Other Study ID Numbers  ICMJE EQ001-19-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Equillium
Study Sponsor  ICMJE Equillium
Collaborators  ICMJE Biocon Limited
Investigators  ICMJE
Principal Investigator: Jo A Douglass, MD Melbourne Health
PRS Account Equillium
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP