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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04007198




Registration number
NCT04007198
Ethics application status
Date submitted
27/06/2019
Date registered
5/07/2019

Titles & IDs
Public title
A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma
Scientific 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
Secondary ID [1] 0 0
EQ001-19-001
Universal Trial Number (UTN)
Trial acronym
EQUIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EQ001
Treatment: Drugs - EQ001 Placebo

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

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.


Treatment: Drugs: EQ001
Itolizumab \[Bmab 600\]

Treatment: Drugs: EQ001 Placebo
EQ001 Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment Emergent Adverse Events
Timepoint [1] 0 0
Study Day 85
Secondary outcome [1] 0 0
Time to maximum EQ001serum concentration, Tmax
Timepoint [1] 0 0
Study Day 85
Secondary outcome [2] 0 0
Maximum EQ001 serum drug concentration, Cmax
Timepoint [2] 0 0
Study Day 85
Secondary outcome [3] 0 0
Minimum EQ001 serum drug concentration, Cmin
Timepoint [3] 0 0
Study Day 85
Secondary outcome [4] 0 0
Total EQ001 exposure across time, AUC (from zero to infinity)
Timepoint [4] 0 0
Study Day 85
Secondary outcome [5] 0 0
Volume of distribution of EQ001, Vd
Timepoint [5] 0 0
Study Day 85
Secondary outcome [6] 0 0
Clearance, Cl
Timepoint [6] 0 0
Study Day 85
Secondary outcome [7] 0 0
Inflammatory Markers
Timepoint [7] 0 0
Study Day 85
Secondary outcome [8] 0 0
CD6 receptor expression
Timepoint [8] 0 0
Study Day 85

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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, a1 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/10/2021
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [5] 0 0
Respiratory Clinical Trials - Kent Town
Recruitment hospital [6] 0 0
TrialsWest - Murdoch
Recruitment hospital [7] 0 0
Melbourne Health - Parkville
Recruitment hospital [8] 0 0
Paratus Clinical Research Western Sydney - Sydney
Recruitment hospital [9] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Kanwal
Recruitment postcode(s) [5] 0 0
- Kent Town
Recruitment postcode(s) [6] 0 0
- Murdoch
Recruitment postcode(s) [7] 0 0
- Parkville
Recruitment postcode(s) [8] 0 0
- Sydney
Recruitment postcode(s) [9] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Dunedin
Country [3] 0 0
New Zealand
State/province [3] 0 0
Greenlane
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Equillium
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Biocon Limited
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Equillium AUS Pty Ltd
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jo A Douglass, MD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04007198