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A Phase 2 Multicenter Study of TL-895 in Subjects with Myelofibrosis, Indolent Systemic Mastocytosis, Monoclonal Mast Cell Activation Syndrome, or Non-Monoclonal Mast Cell Activation Syndrome

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514467-26-00
Acronym
TL-895-201
Enrollment
143
Registered
2024-07-11
Start date
2021-04-07
Completion date
Unknown
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indolent Systemic Mastocytosis

Brief summary

Cohorts 1-4: Part A: Determine the RP2D of TL-895, Cohorts 1-4: Part B: The proportion of subjects achieving ≥ 50% reduction in TSS at Week 24 by MFSAF v4.0, Cohort 5: Part A: The recommended TL-895 dosing regimen(s) will be determined based on safety, efficacy, and tolerability data, Cohort 5: Part B Mean change in ISM-TSAF TSS from Baseline to Week 24, Cohort 6: Part A: The recommended phase 3 dose will be determined based on safety, efficacy, and tolerability data

Detailed description

Cohorts 1-4: Part A: The proportion of subjects achieving ≥ 35% SVR at Week 24 by magnetic resonance imaging (MRI) or computed tomography (CT) scan (central review), Cohorts 1-4: Part B: The proportion of subjects achieving a platelet response defined as per International Working Group – Myeloproliferative Neoplasms Research and Treatment (IWG-MRT 2006) criteria specified in the study protocol, Cohort 5: Part B: Changes in patient reported symptoms

Interventions

DRUGTL-895
DRUGTL-895 matching placebo

Sponsors

Telios Pharma Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Cohorts 1-4: Part A: Determine the RP2D of TL-895, Cohorts 1-4: Part B: The proportion of subjects achieving ≥ 50% reduction in TSS at Week 24 by MFSAF v4.0, Cohort 5: Part A: The recommended TL-895 dosing regimen(s) will be determined based on safety, efficacy, and tolerability data, Cohort 5: Part B Mean change in ISM-TSAF TSS from Baseline to Week 24, Cohort 6: Part A: The recommended phase 3 dose will be determined based on safety, efficacy, and tolerability data—

Secondary

MeasureTime frame
Cohorts 1-4: Part A: The proportion of subjects achieving ≥ 35% SVR at Week 24 by magnetic resonance imaging (MRI) or computed tomography (CT) scan (central review), Cohorts 1-4: Part B: The proportion of subjects achieving a platelet response defined as per International Working Group – Myeloproliferative Neoplasms Research and Treatment (IWG-MRT 2006) criteria specified in the study protocol, Cohort 5: Part B: Changes in patient reported symptoms—

Countries

Belgium, Bulgaria, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026