Trial · NCT04007198
A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma
NCT04007198, Phase 1, Completed, Biocon Limited; results first posted 2025-04-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma. Trials, record NCT04007198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04007198
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma
- NCT number
- NCT04007198
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- Biocon Limited
- Conditions
- Asthma
- Interventions
- EQ001, EQ001 Placebo
- First posted
- 2019-07-05
- Last updated
- 2026-06-02
- Results first posted
- 2025-04-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment Emergent Adverse Events | Study Day 85 | Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
| Secondary | Time to Maximum EQ001serum Concentration, Tmax | Study Day 85 | Time to maximum EQ001 serum concentration, Tmax |
| Secondary | Maximum EQ001 Serum Drug Concentration, Cmax | Study Day 85 | Maximum EQ001 serum drug concentration, Cmax |
| Secondary | Minimum EQ001 Serum Drug Concentration, Cmin | Study Day 85 | Minimum EQ001 serum drug concentration prior to next dose, Cmin |
| Secondary | Total EQ001 Exposure Across Time, AUC (From Zero to Infinity) | Study Day 85 | Total EQ001 exposure across time, AUC (from zero to infinity) |
| Secondary | Volume of Distribution of EQ001, Vd | Study Day 85 | Volume of distribution of EQ001, Vd |
| Secondary | Clearance, Cl | Study Day 85 | Clearance, Cl |
| Secondary | Inflammatory Markers | 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 |
| Secondary | CD6 Receptor Expression | Study Day 85 | the % levels of free versus EQ001-bound CD6 receptor on T cells |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment Emergent Adverse Events | Study Day 85 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Maximum EQ001serum Concentration, Tmax | Study Day 85 | |||
| SECONDARY | Maximum EQ001 Serum Drug Concentration, Cmax | Study Day 85 | |||
| SECONDARY | Minimum EQ001 Serum Drug Concentration, Cmin | Study Day 85 | |||
| SECONDARY | Total EQ001 Exposure Across Time, AUC (From Zero to Infinity) | Study Day 85 | |||
| SECONDARY | Volume of Distribution of EQ001, Vd | Study Day 85 | |||
| SECONDARY | Clearance, Cl | Study Day 85 | |||
| SECONDARY | Inflammatory Markers | Study Day 85 | |||
| SECONDARY | CD6 Receptor Expression | Study Day 85 |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment Emergent Adverse Events | EQ001 0.8mg/kg | 6 | Participants | ||
| Number of Treatment Emergent Adverse Events | EQ001 Placebo | 1 | Participants | ||
| Number of Treatment Emergent Adverse Events | EQ001 1.6mg/kg | 7 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EQ001 0.8mg/kg | 7 | |
| Overall Study | STARTED | EQ001 Placebo | 4 | |
| Overall Study | STARTED | EQ001 1.6mg/kg | 7 | |
| Overall Study | COMPLETED | EQ001 0.8mg/kg | 6 | |
| Overall Study | COMPLETED | EQ001 Placebo | 4 | |
| Overall Study | COMPLETED | EQ001 1.6mg/kg | 6 | |
| Overall Study | NOT COMPLETED | EQ001 0.8mg/kg | 1 | |
| Overall Study | NOT COMPLETED | EQ001 Placebo | 0 | |
| Overall Study | NOT COMPLETED | EQ001 1.6mg/kg | 1 |
Source ClinicalTrials.gov
Adverse events33
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphopenia | Blood and lymphatic system disorders | EQ001 0.8mg/kg | 5 | 7 | 5 |
| other | Lymphopenia | Blood and lymphatic system disorders | EQ001 1.6mg/kg | 6 | 7 | 6 |
| other | Lymphopenia | Blood and lymphatic system disorders | EQ001 Placebo | 0 | 4 | 0 |
| other | Injection site reaction | General disorders | EQ001 0.8mg/kg | 4 | 7 | 4 |
| other | Injection site reaction | General disorders | EQ001 1.6mg/kg | 2 | 7 | 2 |
| other | Injection site reaction | General disorders | EQ001 Placebo | 0 | 4 | 0 |
| other | Injection site rash | General disorders | EQ001 0.8mg/kg | 1 | 7 | 1 |
| other | Injection site rash | General disorders | EQ001 1.6mg/kg | 1 | 7 | 1 |
| other | Injection site rash | General disorders | EQ001 Placebo | 0 | 4 | 0 |
| other | Injection related reaction | Injury, poisoning and procedural complications | EQ001 0.8mg/kg | 1 | 7 | 1 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EQ001 0.8mg/kg | 0 | 7 |
| Total, all-cause mortality | EQ001 1.6mg/kg | 0 | 7 |
| Total, all-cause mortality | EQ001 Placebo | 0 | 4 |
| Total, other adverse events | EQ001 0.8mg/kg | 6 | 7 |
| Total, other adverse events | EQ001 1.6mg/kg | 7 | 7 |
| Total, other adverse events | EQ001 Placebo | 1 | 4 |
| Total, serious adverse events | EQ001 0.8mg/kg | 0 | 7 |
| Total, serious adverse events | EQ001 1.6mg/kg | 1 | 7 |
| Total, serious adverse events | EQ001 Placebo | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04007198
GET https://conductscience.org/api/trials/v1/NCT04007198/events?page=2