Trial · NCT07598825
A Trial of Inebilizumab in Participants With Autoimmune Hepatitis
NCT07598825, Phase 3, Recruiting, Amgen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Inebilizumab in Participants With Autoimmune Hepatitis. Trials, record NCT07598825. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07598825
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Inebilizumab in Participants With Autoimmune Hepatitis
- NCT number
- NCT07598825
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 180 participants, estimated
- Lead sponsor
- Amgen
- Conditions
- Autoimmune Hepatitis, AIH
- Interventions
- Inebilizumab, Placebo, Standard of Care
- First posted
- 2026-05-20
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Interest at Week 26 | Up to Week 26 | |
| Primary | Part 2: Number of Participants who Achieved Modified Histologic Activity Index (mHAI) ≤ 3 and Stable Prednisone Dose (or equivalent) ≤ 5 mg/day at Week 78 | Week 78 | Participants who met the two outcomes combined will be reported for this endpoint. |
| Secondary | Part 1: Number of Participants who Achieved Normal Alanine Aminotransferase (ALT) Levels at Week 26 | Week 26 | |
| Secondary | Part 1: Change from Baseline in ALT Levels at Week 26 | Baseline and Week 26 | |
| Secondary | Part 1: Maximum Serum Concentration (Cmax) of Inebilizumab | Up to Week 26 | |
| Secondary | Part 1: Area Under the Serum Concentration-time Curve (AUC) of Inebilizumab | Up to Week 26 | |
| Secondary | Part 1: Change from Baseline in Peripheral B Cell Counts at Week 26 | Baseline and Week 26 | |
| Secondary | Part 2: Number of Participants who Achieved Sustained Normal ALT Levels and Stable Prednisone Dose (or equivalent) ≤ 5 mg/day by Week 78 | Week 78 | Sustained normal ALT levels is defined as achieving normal ALT levels in the 3 consecutive visits. Participants who met the two outcomes combined will be reported for this endpoint. |
| Secondary | Part 2: Number of Participants who Achieved Normal ALT Levels, mHAI ≤ 3 and Stable Prednisone Dose (or equivalent) ≤ 5 mg/day at Week 78 | Week 78 | Participants who met the three outcomes combined will be reported for this endpoint. |
| Secondary | Part 2: Number of Participants who Achieved Stable Prednisone Dose (or equivalent) ≤ 5 mg/day by Week 78 | Week 78 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 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/NCT07598825
GET https://conductscience.org/api/trials/v1/NCT07598825/registered?page=2