Trial Outcomes & Findings for A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma (NCT NCT04007198)
NCT ID: NCT04007198
Last Updated: 2025-04-18
Results Overview
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Study Day 85
Results posted on
2025-04-18
Participant Flow
Cohorts for dose 2.4mg/kg and 3.2mg/kg were not conducted. Data for placebo subjects in cohort for 0.8mg/kg and 1.6mg/kg were pooled in analysis.
Participant milestones
| Measure |
EQ001 0.8mg/kg
EQ001 administered in a blinded fashion by subcutaneous injection every two weeks for a total of 5 doses at 0.8mg/kg EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Placebo
EQ001 Placebo administered in a blinded fashion by subcutaneous injection every two weeks for a total of 5 doses.
EQ001 Placebo: EQ001 Placebo
|
EQ001 1.6mg/kg
EQ001 administered in a blinded fashion by subcutaneous injection every two weeks for a total of 5 doses at 1.6mg/kg EQ001: Itolizumab \[Bmab 600\]
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
7
|
|
Overall Study
COMPLETED
|
6
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma
Baseline characteristics by cohort
| Measure |
EQ001 0.8mg/kg
n=7 Participants
EQ001 administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses at 0.8mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Placebo
n=4 Participants
Placebo administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.
EQ001 Placebo: EQ001 Placebo
|
EQ001 1.6mg/kg
n=7 Participants
EQ001 administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses at 1.6mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 15.59 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 6.73 • n=7 Participants
|
50.1 years
STANDARD_DEVIATION 18.53 • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 14.84 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
16 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Study Day 85Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Outcome measures
| Measure |
EQ001 0.8mg/kg
n=7 Participants
EQ001 administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses at 0.8mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Placebo
n=4 Participants
Placebo administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.
EQ001 Placebo: EQ001 Placebo
|
EQ001 1.6mg/kg
n=7 Participants
EQ001 administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses at 1.6mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
|---|---|---|---|
|
Number of Treatment Emergent Adverse Events
|
6 Participants
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Study Day 85Time to maximum EQ001 serum concentration, Tmax
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 85Maximum EQ001 serum drug concentration, Cmax
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 85Minimum EQ001 serum drug concentration prior to next dose, Cmin
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 85Total EQ001 exposure across time, AUC (from zero to infinity)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 85Volume of distribution of EQ001, Vd
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 85Clearance, Cl
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 85Including 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study Day 85the % levels of free versus EQ001-bound CD6 receptor on T cells
Outcome measures
Outcome data not reported
Adverse Events
EQ001 0.8mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
EQ001 1.6mg/kg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
EQ001 Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EQ001 0.8mg/kg
n=7 participants at risk
EQ001 administered in a blinded fashion by subcutaneous injection every two weeks for a total of 5 doses at 0.8mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 1.6mg/kg
n=7 participants at risk
EQ001 administered in a blinded fashion by subcutaneous injection every two weeks for a total of 5 doses at 1.6mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Placebo
n=4 participants at risk
Placebo administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.
EQ001 Placebo: EQ001 Placebo
|
|---|---|---|---|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/7 • Time Frame: Study Day 85
|
14.3%
1/7 • Number of events 1 • Time Frame: Study Day 85
|
0.00%
0/4 • Time Frame: Study Day 85
|
Other adverse events
| Measure |
EQ001 0.8mg/kg
n=7 participants at risk
EQ001 administered in a blinded fashion by subcutaneous injection every two weeks for a total of 5 doses at 0.8mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 1.6mg/kg
n=7 participants at risk
EQ001 administered in a blinded fashion by subcutaneous injection every two weeks for a total of 5 doses at 1.6mg/kg.
EQ001: Itolizumab \[Bmab 600\]
|
EQ001 Placebo
n=4 participants at risk
Placebo administered in a blinded dose escalating cohort fashion by subcutaneous injection every two weeks for a total of 5 doses.
EQ001 Placebo: EQ001 Placebo
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
71.4%
5/7 • Number of events 5 • Time Frame: Study Day 85
|
85.7%
6/7 • Number of events 6 • Time Frame: Study Day 85
|
0.00%
0/4 • Time Frame: Study Day 85
|
|
General disorders
Injection site reaction
|
57.1%
4/7 • Number of events 4 • Time Frame: Study Day 85
|
28.6%
2/7 • Number of events 2 • Time Frame: Study Day 85
|
0.00%
0/4 • Time Frame: Study Day 85
|
|
General disorders
Injection site rash
|
14.3%
1/7 • Number of events 1 • Time Frame: Study Day 85
|
14.3%
1/7 • Number of events 1 • Time Frame: Study Day 85
|
0.00%
0/4 • Time Frame: Study Day 85
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
14.3%
1/7 • Number of events 1 • Time Frame: Study Day 85
|
42.9%
3/7 • Number of events 3 • Time Frame: Study Day 85
|
0.00%
0/4 • Time Frame: Study Day 85
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Time Frame: Study Day 85
|
14.3%
1/7 • Number of events 1 • Time Frame: Study Day 85
|
25.0%
1/4 • Number of events 1 • Time Frame: Study Day 85
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
1/7 • Number of events 1 • Time Frame: Study Day 85
|
0.00%
0/7 • Time Frame: Study Day 85
|
0.00%
0/4 • Time Frame: Study Day 85
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1 • Time Frame: Study Day 85
|
0.00%
0/7 • Time Frame: Study Day 85
|
0.00%
0/4 • Time Frame: Study Day 85
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • Time Frame: Study Day 85
|
14.3%
1/7 • Number of events 1 • Time Frame: Study Day 85
|
0.00%
0/4 • Time Frame: Study Day 85
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Time Frame: Study Day 85
|
14.3%
1/7 • Number of events 1 • Time Frame: Study Day 85
|
0.00%
0/4 • Time Frame: Study Day 85
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/7 • Time Frame: Study Day 85
|
14.3%
1/7 • Number of events 1 • Time Frame: Study Day 85
|
0.00%
0/4 • Time Frame: Study Day 85
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60