Trial · NCT04128579
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
NCT04128579, Phase 1, Completed, Biocon Limited; results first posted 2025-04-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis. Trials, record NCT04128579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04128579
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
- NCT number
- NCT04128579
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 52 participants, actual
- Lead sponsor
- Biocon Limited
- Conditions
- Lupus Erythematosus, Lupus Nephritis
- Interventions
- Itolizumab [Bmab 600]
- First posted
- 2019-10-16
- Last updated
- 2026-06-04
- Results first posted
- 2025-04-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment Emergent Adverse Events | Type A up to Day 57 or Type B up to Day 253 | Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
| Secondary | To Characterize the PK of Itolizumab | Type A up to Day 57 or Type B up to Day 253 | To characterize the pharmacokinetics of itolizumab |
| Secondary | CD6 Receptor Occupancy | Type A up to Day 57 or Type B up to Day 253 | the % levels of free versus EQ001-bound CD6 receptor on T cells |
Source ClinicalTrials.gov
Outcomes3
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 | Type A up to Day 57 or Type B up to Day 253 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | To Characterize the PK of Itolizumab | Type A up to Day 57 or Type B up to Day 253 | |||
| SECONDARY | CD6 Receptor Occupancy | Type A up to Day 57 or Type B up to Day 253 |
Source ClinicalTrials.gov
Results by group6
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 Type A Cohort (0.4mg/kg) | 0 | Participants | ||
| Number of Treatment Emergent Adverse Events | EQ001 for Type B Cohort | 17 | Participants | ||
| Number of Treatment Emergent Adverse Events | EQ001 Type A Cohort (0.8mg/kg) | 2 | Participants | ||
| Number of Treatment Emergent Adverse Events | EQ001 Type A Cohort (1.6mg/kg) | 4 | Participants | ||
| Number of Treatment Emergent Adverse Events | EQ001 Type A Cohort (2.4mg/kg) | 3 | Participants | ||
| Number of Treatment Emergent Adverse Events | EQ001 Type A Cohort (3.2mg/kg) | 8 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EQ001 Type A Cohort (0.4mg/kg) | 6 | |
| Overall Study | STARTED | EQ001 for Type B Cohort | 17 | |
| Overall Study | STARTED | EQ001 Type A Cohort (0.8mg/kg) | 7 | |
| Overall Study | STARTED | EQ001 Type A Cohort (1.6mg/kg) | 7 | |
| Overall Study | STARTED | EQ001 Type A Cohort (2.4mg/kg) | 6 | |
| Overall Study | STARTED | EQ001 Type A Cohort (3.2mg/kg) | 9 | |
| Overall Study | COMPLETED | EQ001 Type A Cohort (0.4mg/kg) | 6 | |
| Overall Study | COMPLETED | EQ001 for Type B Cohort | 14 | |
| Overall Study | COMPLETED | EQ001 Type A Cohort (0.8mg/kg) | 6 | |
| Overall Study | COMPLETED | EQ001 Type A Cohort (1.6mg/kg) | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events528
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 | Injection site erythema | General disorders | EQ001 Type A Cohort (0.4mg/kg) | 0 | 6 | 0 |
| other | Injection site erythema | General disorders | EQ001 for Type B Cohort | 0 | 17 | 0 |
| other | Injection site erythema | General disorders | EQ001 Type A Cohort (0.8mg/kg) | 1 | 7 | 1 |
| other | Injection site erythema | General disorders | EQ001 Type A Cohort (1.6mg/kg) | 2 | 7 | 2 |
| other | Injection site erythema | General disorders | EQ001 Type A Cohort (2.4mg/kg) | 0 | 6 | 0 |
| other | Injection site erythema | General disorders | EQ001 Type A Cohort (3.2mg/kg) | 3 | 9 | 3 |
| other | Injection site pruritus | General disorders | EQ001 Type A Cohort (0.4mg/kg) | 0 | 6 | 0 |
| other | Injection site pruritus | General disorders | EQ001 for Type B Cohort | 0 | 17 | 0 |
| other | Injection site pruritus | General disorders | EQ001 Type A Cohort (0.8mg/kg) | 0 | 7 | 0 |
| other | Injection site pruritus | General disorders | EQ001 Type A Cohort (1.6mg/kg) | 1 | 7 | 1 |
1 to 10 of 528Source ClinicalTrials.gov
See all 528 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EQ001 Type A Cohort (0.4mg/kg) | 0 | 6 |
| Total, all-cause mortality | EQ001 for Type B Cohort | 0 | 17 |
| Total, all-cause mortality | EQ001 Type A Cohort (0.8mg/kg) | 0 | 7 |
| Total, all-cause mortality | EQ001 Type A Cohort (1.6mg/kg) | 0 | 7 |
| Total, all-cause mortality | EQ001 Type A Cohort (2.4mg/kg) | 0 | 6 |
| Total, all-cause mortality | EQ001 Type A Cohort (3.2mg/kg) | 0 | 9 |
| Total, other adverse events | EQ001 Type A Cohort (0.4mg/kg) | 0 | 6 |
| Total, other adverse events | EQ001 for Type B Cohort | 17 | 17 |
| Total, other adverse events | EQ001 Type A Cohort (0.8mg/kg) | 2 | 7 |
| Total, other adverse events | EQ001 Type A Cohort (1.6mg/kg) | 4 | 7 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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/NCT04128579
GET https://conductscience.org/api/trials/v1/NCT04128579/events?page=2