Trial · NCT05186753
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Determine recommended dose of bezuclastinib (CGT9486) in subjects with NonAdvSM | 3 months | Selection of the recommended dose to be used in subsequent parts of the study. |
| Primary | Part 2: Efficacy of bezuclastinib at the selected dose versus placebo | 24 Weeks | Mean absolute change on the Mastocytosis Symptom Severity Daily Diary (MS2D2) |
| Primary | Part 3: Safety and tolerability of bezuclastinib as assessed by number of adverse events | Up to 5 years | CTCAE v5 |
| Secondary | Part 2: Proportion of subjects who had at least 50% reduction in serum tryptase | 24 weeks | |
| Secondary | Part 2: Proportion of subjects who had at least a 50% reduction in peripheral blood D816V allele fraction | 24 weeks | |
| Secondary | Part 2: Determine responder rates of subjects treated with bezuclastinib at the selected dose versus placebo | 24 weeks | Proportion of subjects with at least a 30% reduction of the total symptom score (TSS) on the MS2D2. Proportion of subjects with at least a 50% reduction of the total symptom score (TSS) on the MS2D2. |
| Secondary | Part 2: Proportion of subjects who had at least 50% reduction in mast cell burden | 24 weeks | |
| Secondary | Parts 1 & 2: Safety and tolerability of bezuclastinib as assessed by number of adverse events | Up to 24 weeks | CTCAE v5 |
| Secondary | Parts 1, 2, & 3: Change and percent change in patient reported outcome (PRO) measures | Up to 5 years | |
| Secondary | Parts 1 & 3: Change and percent change in serum tryptase | Up to 12 months | |
| Secondary | Parts 1 & 3: Change and percent change in bone marrow mast cells | Up to 18 months | |
| Secondary | Part 1: Assess the pharmacokinetics (PK) of bezuclastinib in subjects with NonAdvSM | 3 months | Plasma concentrations of CGT9846 |
| Secondary | Part 2: Determine mean change from baseline in predetermined PRO sub-domain and individual item scores | 24 weeks | |
| Secondary | Parts 2 & 3: Determine change of the lead (most severe) symptom and lead (most severe) subdomain of the MS2D2 in subjects treated with bezuclastinib versus placebo | Up to 5 years | Change and percent change from baseline in the symptom score of the subject's most severe symptom. Change and percent change from baseline in the MS2D2 subdomain score of the subject's most severe subdomain. |
| Secondary | Part 3: Change and percent change in the levels of KIT D816V mutation allele burden | Up to 12 months | |
| Secondary | Part 3: To determine the efficacy of bezuclastinib at the selected dose | Up to 2 years | Proportion of subjects with at least a 50% reduction in MS2D2 TSS from baseline at 1 year and 2 years from start of bezuclastinib Change and percent change from baseline in the MS2D2 TSS, subdomain, and individual item scores |
| Secondary | Part 3: Usage of concomitant medications as rescue therapy for NonAdvSM and changes from baseline in rescue therapy and best supportive care medications regimen | Up to 5 years | |
| Other | Substudy: Efficacy of bezuclastinib at selected dose in subjects whose symptoms are not adequately controlled by avapritinib | Up to 2 years | Mean absolute change on the Mastocytosis Symptom Severity Daily Diary (MS2D2) |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05186753/registered