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

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Equillium
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Updated on 20 September 2024
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fluticasone
albuterol
anticholinergics
forced expiratory volume
bronchial provocation test

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.

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.

Details
Condition Asthma, Asthma, Asthma (Pediatric), Allergies & Asthma, Asthma (Pediatric), Allergies & Asthma
Age 18years - 75years
Treatment EQ001, EQ001 Placebo
Clinical Study IdentifierNCT04007198
SponsorEquillium
Last Modified on20 September 2024

Eligibility

 Yes No Not Sure

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 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
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

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, 1 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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