Trial · NCT05823675
Safety and Clinical Activity of Itolizumab in aGVHD
NCT05823675, Phase 1, Unknown, Biotech Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Clinical Activity of Itolizumab in aGVHD. Trials, record NCT05823675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05823675
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Clinical Activity of Itolizumab in aGVHD
- NCT number
- NCT05823675
- Status
- Unknown
- Phases
- Phase 1
- Enrollment
- 44 participants, estimated
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Conditions
- Acute Graft Versus Host Disease
- Interventions
- Itolizumab, Methylprednisolone
- First posted
- 2023-04-21
- Last updated
- 2023-05-25
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment Emergent Adverse Events | Study Day 85 | Number of subjects with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0 |
| Secondary | Time to maximum Itolizumab serum concentration, Tmax | Study Day 85 | Time to maximum Itolizumab serum concentration |
| Secondary | Maximum Itolizumab serum drug concentration, Cmax | Study Day 85 | Maximum Itolizumab serum drug concentration |
| Secondary | Minimum Itolizumab serum drug concentration, Cmin | Study Day 85 | Minimum Itolizumab serum drug concentration |
| Secondary | Total Itolizumab exposure across time, AUC | Study Day 85 | Total Itolizumab exposure across time, AUC |
| Secondary | Half life of Itolizumab, t1/2 | Study Day 85 | Half life of Itolizumab |
| Secondary | Volume of distribution of Itolizumab, Vd | Study Day 85 | Volume of distribution of Itolizumab |
| Secondary | Clearance, Cl | Study Day 85 | Clearance |
| Secondary | CD6 receptor expression levels on T cells | Study Day 85 | CD6 receptor expression levels |
| Secondary | T cell subsets | Study Day 85 | T cell subsets |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT05823675
GET https://conductscience.org/api/trials/v1/NCT05823675/registered