Trial · NCT05569759
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients Who Achieved Complete Biochemical Response | Week 12, Week 16, Week 20, and Week 24 | The number of patients who achieve complete biochemical response (CR), defined as normal ALT, AST, and IgG values (if IgG level is elevated at Baseline) with glucocorticoid dose not higher than starting dose (at Baseline), by Week 24 of the Double-Blind Treatment Period. Analyses were also conducted at Week 12, Week 16, and Week 20. |
| Primary | The Safety and Tolerability of Zetomipzomib | Baseline through end of study visit (DBTP, Week 28 and OLE, Up to Week 24) | Proportion of participants who experience AEs (adverse events) and SAEs (serious adverse events) during the double-blind treatment period (DBTP) and the open-label extension (OLE). |
| Primary | Proportion of Participants Experiencing a Disease Flare Among the Participants Who Achieved a CR During the Double-blind Treatment Period | Start of open-label extension (OLE) period through End of Study (EOS) up to OLE Week 25 | Proportion of participants experiencing a disease flare among the participants who achieved a complete biochemical response (CR) during the double-blind treatment period. |
| Secondary | Alanine Aminotransferase (ALT) | Weeks 12, 16, 20, and 24 | Changes from baseline in alanine aminotransferase (ALT) during the double-blind treatment period. |
| Secondary | Partial Response | Weeks 12, 16, 20, and 24 | Proportion of participants who achieved a partial response (PR) during the double-blind treatment period of the study. |
| Secondary | Time to Complete Response | Baseline through Week 24 | Time to complete response (CR), defined as the duration from first dose of study drug (zetomipzomib or placebo) to first CR, during the double-blind treatment period was measured using the Kaplan-Meier method. Due to the small sample size, not enough events of participants achieving CR were observed to provide Kaplan-Meier estimates for the 25th percentile, median, and 75th percentile time to CR. |
| Secondary | Disease Flare After CR | Week 24 | Proportion of participants who experienced a disease flare after complete response (CR) during the double-blind treatment period. |
| Secondary | Treatment Failures | Week 24 | Proportion of participants who were considered treatment failures, defined as ALT or AST level worsened ≥2 times that of the Baseline value that is sustained for ≥1 week as verified via repeat laboratory assessments, despite compliance with standard of care (ie, with regard to inclusion criteria) or protocol-defined therapy or a glucocorticoid dose is increased above the Baseline dose, it may be considered a treatment failure unless attributed to an adverse event not relating to AIH, during the double-blind treatment period. |
| Secondary | Complete Response With Glucocorticoid Taper to ≤10 mg | Weeks 12, 16, 20, and 24 | Percentage of participants who achieved complete response with successful glucocorticoid taper to ≤10 mg by Week 24 of the double-blind treatment period. |
| Secondary | Complete Response With Glucocorticoid Taper to ≤5 mg | Weeks 12, 16, 20, and 24 | Percentage of participants who achieved complete response and glucocorticoid taper to ≤5 mg by Week 24 of the double-blind treatment period. |
| Secondary | Complete Response With Glucocorticoid Taper to 0 mg | Weeks 12, 16, 20, and 24 | Percentage of participants who achieved complete response with glucocorticoid taper to 0 mg by Week 24 of the double-blind treatment period. |
| Secondary | Partial Response With Glucocorticoid Taper to ≤10 mg | Week 24 | Percentage of participants who achieved partial response with successful glucocorticoid taper to ≤10 mg by Week 24 of the double-blind treatment period. |
| Secondary | Partial Response With Glucocorticoid Taper to ≤5 mg | Week 24 | Percentage of participants who achieved partial response and glucocorticoid taper to ≤5 mg by Week 24 of the double-blind treatment period. |
| Secondary | Partial Response With Glucocorticoid Taper to 0 mg | Week 24 | Percentage of participants who achieved partial response with glucocorticoid taper to 0 mg by Week 24 of the double-blind treatment period. |
| Other | Change From Baseline in Glucocorticoid Dose | Weeks 12, 16, 20, and 24 | Mean change from Baseline in glucocorticoid dose for participants during the double-blind treatment period at Weeks 12, 16, 20 and 24 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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