Clinical trial • Phase II • Haematology

1-4-{[6-AMINO-5-(4-PHENOXY-PHENYL)-PYRIMIDIN-4-YLAMINO]-METHYL}-4-FLUORO-PIPERIDIN-1-YL)-PROPENONE for Myelofibrosis | Indolent systemic mastocytosis | Monoclonal mast cell activation syndrome | Non-monoclonal mast cell activation syndrome

Phase II trial of 1-4-{[6-AMINO-5-(4-PHENOXY-PHENYL)-PYRIMIDIN-4-YLAMINO]-METHYL}-4-FLUORO-PIPERIDIN-1-YL)-PROPENONE for Myelofibrosis | Indolent systemic…

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Myelofibrosis | Indolent systemic mastocytosis | Monoclonal mast cell activation syndrome | Non-monoclonal mast cell activation syndrome
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
13-06-2024
First CTIS Authorization Date
11-07-2024

Trial design

Randomised, open-label, tl-895 matching placebo is used as a placebo comparator (cohort 5 part c compares tl-895 vs placebo). dose and schedule details are not specified in the ctis json.-controlled, adaptive Phase II trial across 38 sites in Belgium, Bulgaria, France and others.

Randomised
Yes
Open Label
Yes
Comparator
TL-895 matching placebo is used as a placebo comparator (Cohort 5 Part C compares TL-895 vs placebo). Dose and schedule details are not specified in the CTIS JSON.
Adaptive
True, Part A is a dose-finding/adaptive component to determine recommended phase 2 and phase 3 doses and schedules (cohort-based dose determination/escalation). Specific dose-escalation rules or interim decision rules are not provided in the CTIS JSON.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
120
Trial Duration For Participant
168

Eligibility

Recruits 120 Vulnerable population selected. The trial enrols adults (≥18 years). Informed consent is managed via subject information and informed consent forms (multiple country- and language-specific versions are listed in the CTIS documents, including dedicated 'Pregnant Partner' and 'Genetic Sample' consent materials), indicating consent is sought using ICFs; no child assent details are provided in the CTIS record..

Vulnerable Population
Vulnerable population selected. The trial enrols adults (≥18 years). Informed consent is managed via subject information and informed consent forms (multiple country- and language-specific versions are listed in the CTIS documents, including dedicated 'Pregnant Partner' and 'Genetic Sample' consent materials), indicating consent is sought using ICFs; no child assent details are provided in the CTIS record.

Inclusion criteria

  • {"criterion_text":"- Cohorts 1-6: Adults ≥18 years of age\n- Cohort 4 only: Ineligibility for JAKi treatment with a platelet count of ≥ 15 and < 25x10^9/L\n- Cohort 6: Moderate-to-severe chronic MCAS symptoms\n- Cohort 6: Subject must have failed to achieve symptom control for one or more baseline chronic symptoms\n- Cohort 6: The subject’s symptomatic MCAS therapies must be stable\n- Cohorts 1-4: Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria\n- Cohorts 1-4: High-risk, intermediate-2 risk, or intermediate-1 risk, defined by DIPSS\n- Cohorts 1-6: Adequate hematologic, hepatic, and renal functions\n- Cohorts 1-4: MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7 to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0\n- Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and < 50 x 10^9/L\n- Cohort 5: Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results\n- Cohort 5: Subject must have moderate-to-severe symptoms\n- Cohort 6: Confirmed diagnosis of MCAS as defined by Working Group diagnostic criteria"}

Exclusion criteria

  • {"criterion_text":"- Cohorts 1-4: Prior treatment with JAKi within 28 days prior to first study treatment\n- Cohorts 1-4: Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment\n- Cohort 5: Diagnosis with another myeloid disorder\n- Cohort 6: A current diagnosis of cutaneous or systemic mastocytosis as defined by WHO criteria"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Cohorts 1-4: Part A: Determine the RP2D of TL-895","definition_or_measurement_approach":"Determine the recommended phase 2 dose (RP2D) and schedule of TL-895 in each cohort based on safety, tolerability, and other data collected in Part A (dose-finding/cohort escalation)."}
  • {"endpoint_text":"- Cohorts 1-4: Part B: The proportion of subjects achieving ≥ 50% reduction in TSS at Week 24 by MFSAF v4.0","definition_or_measurement_approach":"Proportion of subjects with ≥50% reduction in Total Symptom Score (TSS) at Week 24 assessed using the MFSAF v4.0 instrument."}
  • {"endpoint_text":"- Cohort 5: Part A: The recommended TL-895 dosing regimen(s) will be determined based on safety, efficacy, and tolerability data","definition_or_measurement_approach":"Selection of recommended dosing regimen(s) for TL-895 in Cohort 5 based on integrated assessment of safety, efficacy and tolerability from Part A (dose-finding evaluation)."}
  • {"endpoint_text":"- Cohort 5: Part B Mean change in ISM-TSAF TSS from Baseline to Week 24","definition_or_measurement_approach":"Mean change from baseline to Week 24 in ISM-TSAF Total Symptom Score (TSS) for Cohort 5."}
  • {"endpoint_text":"- Cohort 6: Part A: The recommended phase 3 dose will be determined based on safety, efficacy, and tolerability data","definition_or_measurement_approach":"Determine recommended phase 3 dose (RP3D) for TL-895 in Cohort 6 based on safety, efficacy and tolerability data from Part A (dose-finding)."}

Secondary endpoints

  • {"endpoint_text":"- 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)","definition_or_measurement_approach":"Proportion of subjects achieving ≥35% spleen volume reduction (SVR) at Week 24 measured by MRI or CT with central review."}
  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion achieving platelet response as defined by IWG-MRT 2006 criteria (as specified in protocol)."}
  • {"endpoint_text":"- Cohort 5: Part B: Changes in patient reported symptoms","definition_or_measurement_approach":"Changes in patient-reported symptoms (e.g., ISM-specific symptom assessments such as ISM-TSAF TSS), as captured by patient questionnaires per protocol."}

Recruitment

Planned Sample Size
120
Recruitment Window Months
110
Consent Approach
Informed consent is obtained via subject information and informed consent forms; multiple country- and language-specific ICFs are listed in the CTIS documents (EN, BG, FR, DU/NL, IT, ES, PL, DE, NO as applicable). Participants are adults (≥18) who provide their own consent. There are also dedicated ICFs for pregnant partners and for genetic sample consent where applicable.

Geography

Total Number Of Sites
38
Total Number Of Participants
188

Belgium

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
672
Number Of Sites
3
Number Of Participants
24

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hematologie voor volwassenen
Principal Investigator Name
Marie-Christiane Vekemans
Principal Investigator Email
marie-christiane.vekemans@uclouvain.be
Contact Person Name
Marie-Christiane Vekemans
Site Name
Antwerp University Hospital
Department Name
Immunologie, allergologie en reumatologie
Principal Investigator Name
Vito Sabato
Principal Investigator Email
vito.sabato@uza.be
Contact Person Name
Vito Sabato
Contact Person Email
vito.sabato@uza.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Hematologie clinique
Principal Investigator Name
Aurélie Jaspers
Principal Investigator Email
aurelie.jaspers@chuliege.be
Contact Person Name
Aurélie Jaspers
Contact Person Email
aurelie.jaspers@chuliege.be

Bulgaria

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
13-02-2025
Processing Time Days
233
Number Of Sites
1
Number Of Participants
13

Sites

Site Name
Military Medical Academy
Department Name
Hematology Clinic
Principal Investigator Name
Viktoria Varbanova
Principal Investigator Email
viktoriia1982@abv.bg
Contact Person Name
Viktoria Varbanova
Contact Person Email
viktoriia1982@abv.bg

France

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
17-02-2025
Processing Time Days
237
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
Centre Hospitalier Le Mans
Department Name
onco-hematology
Principal Investigator Name
Kamel Laribi
Principal Investigator Email
klaribi@ch-lemans.fr
Contact Person Name
Kamel Laribi
Contact Person Email
klaribi@ch-lemans.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
hematology
Principal Investigator Name
Michael Loschi
Principal Investigator Email
loschi.m@chu-nice.fr
Contact Person Name
Michael Loschi
Contact Person Email
loschi.m@chu-nice.fr

Germany

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
672
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus Benjamin Franklin, Institute of Allergology
Principal Investigator Name
Frank Siebenhaar
Principal Investigator Email
frank.siebenhaar@charite.de
Contact Person Name
Frank Siebenhaar
Contact Person Email
frank.siebenhaar@charite.de
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Klinik für Innere Medizin IV- Hämatologie/Onkologie
Principal Investigator Name
Haifa Kathrin Al-Ali
Principal Investigator Email
haifa.al-ali@uk-halle.de
Contact Person Name
Haifa Kathrin Al-Ali
Contact Person Email
haifa.al-ali@uk-halle.de
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
(Internal Medicine, Haematology, Oncology
Principal Investigator Name
Andreas Reiter
Principal Investigator Email
andreas.reiter@medma.uni-heidelberg.de
Contact Person Name
Andreas Reiter
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Department II
Principal Investigator Name
Philippe Schafhausen
Principal Investigator Email
schafhausen@uke.de
Contact Person Name
Philippe Schafhausen
Contact Person Email
schafhausen@uke.de
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Hämatologie und Onkologie
Principal Investigator Name
Nikolaus von Bubnoff
Contact Person Name
Nikolaus von Bubnoff
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin II- Hämatologie und Internistische Onkologie
Principal Investigator Name
Carl Crodel
Principal Investigator Email
carl.crodel@med.uni-jena.de
Contact Person Name
Carl Crodel
Contact Person Email
carl.crodel@med.uni-jena.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Hämatologie, Oncology
Principal Investigator Name
Jens Panse
Principal Investigator Email
jpanse@ukaachen.de
Contact Person Name
Jens Panse
Contact Person Email
jpanse@ukaachen.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Medizinische Klinik und Poliklinik 1, Bereich Hämatologie
Principal Investigator Name
Katja Sockel
Principal Investigator Email
katja.sockel@uniklinikum-dresden.de
Contact Person Name
Katja Sockel

Italy

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
672
Number Of Sites
11
Number Of Participants
34

Sites

Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
UO di Ematologia con T.M.O.
Principal Investigator Name
Giuseppe Palumbo
Principal Investigator Email
studiclinicimpn.unict@gmail.com
Contact Person Name
Giuseppe Palumbo
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Dipartimento medico specialistico e oncologico
Principal Investigator Name
Andrea Patriarca
Principal Investigator Email
andrea.patriarca@uniupo.it
Contact Person Name
Andrea Patriarca
Contact Person Email
andrea.patriarca@uniupo.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC ematologia I
Principal Investigator Name
Chiara Elena
Principal Investigator Email
c.elena@smatteo.pv.it
Contact Person Name
Chiara Elena
Contact Person Email
c.elena@smatteo.pv.it
Site Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Department Name
Divisione di Ematologia
Principal Investigator Name
Maria Bruna Greve
Principal Investigator Email
mariabruna.greve@ospedalerc.it
Contact Person Name
Maria Bruna Greve
Contact Person Email
mariabruna.greve@ospedalerc.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Dipartimento di Ematologia, Oncologia e Dermatologia
Principal Investigator Name
Massimo Breccia
Principal Investigator Email
massimo.breccia@uniroma1.it
Contact Person Name
Massimo Breccia
Contact Person Email
massimo.breccia@uniroma1.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
DIPARTIMENTO MALATTIE ONCOLOGICHE ED EMATOLOGICHE
Principal Investigator Name
Francesca Palandri
Principal Investigator Email
francesca.palandri@unibo.it
Contact Person Name
Francesca Palandri
Contact Person Email
francesca.palandri@unibo.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
UO di Ematologia
Principal Investigator Name
Mariarita Sciumè
Principal Investigator Email
mariarita.sciume@policlinico.mi.it
Contact Person Name
Mariarita Sciumè
Site Name
Azienda Ospedaliera di Padova
Department Name
UOSD Allergologia
Principal Investigator Name
Riccardo Senter
Principal Investigator Email
riccardo.senter@aopd.veneto.it
Contact Person Name
Riccardo Senter
Contact Person Email
riccardo.senter@aopd.veneto.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Divisione di Ematologia
Principal Investigator Name
Marianna Caramella
Principal Investigator Email
marianna.caramella@ospedaleniguarda.it
Contact Person Name
Marianna Caramella
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SOD Ematologia
Principal Investigator Name
Francesco Mannelli
Principal Investigator Email
francesco.mannelli@unifi.it
Contact Person Name
Francesco Mannelli
Contact Person Email
francesco.mannelli@unifi.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna (Ravenna)
Department Name
Dipartimento Di Onco-Ematologia
Principal Investigator Name
Michela Rondoni
Principal Investigator Email
michela.rondoni@auslromagna.it
Contact Person Name
Michela Rondoni
Contact Person Email
michela.rondoni@auslromagna.it

Netherlands

Earliest CTIS Part Ii Submission Date
17-02-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
70
Number Of Sites
1
Number Of Participants
14

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Internal Medicine
Principal Investigator Name
Paul van Daele
Principal Investigator Email
p.l.a.vandaele@erasmusmc.nl
Contact Person Name
Paul van Daele
Contact Person Email
p.l.a.vandaele@erasmusmc.nl

Norway

Earliest CTIS Part Ii Submission Date
27-03-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
32
Number Of Sites
1
Number Of Participants
24

Sites

Site Name
Oslo Universitetssykehus HF
Department Name
Department of Hematology
Principal Investigator Name
Ingunn Dybedal
Principal Investigator Email
idybedal@ous-hf.no
Contact Person Name
Ingunn Dybedal
Contact Person Email
idybedal@ous-hf.no

Poland

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
672
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Uniwersyteckie Centrum Kliniczne (Gdansk)
Department Name
Klinika Alergologii
Principal Investigator Name
Marek Niedoszytko
Principal Investigator Email
marek.niedoszytko@gumed.edu.pl
Contact Person Name
Marek Niedoszytko
Contact Person Email
marek.niedoszytko@gumed.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Nowotworow Krwii i Transplantacji Szpiku
Principal Investigator Name
Tomasz Wrobel
Principal Investigator Email
tomasz_wrobel@wp.pl
Contact Person Name
Tomasz Wrobel
Contact Person Email
tomasz_wrobel@wp.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddzial Kliniczny Hematologii
Principal Investigator Name
Tomasz Sacha
Principal Investigator Email
sachatom@gmail.com
Contact Person Name
Tomasz Sacha
Contact Person Email
sachatom@gmail.com
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Hematologii
Principal Investigator Name
Marta Sobas
Principal Investigator Email
marta.sobas@gmail.com
Contact Person Name
Marta Sobas
Contact Person Email
marta.sobas@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
672
Number Of Sites
7
Number Of Participants
24

Sites

Site Name
Hospital Germans Trias I Pujol
Department Name
Hematology
Principal Investigator Name
Blanca Xicoy Cirici
Principal Investigator Email
bxicoy@iconcologia.net
Contact Person Name
Blanca Xicoy Cirici
Contact Person Email
bxicoy@iconcologia.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Principal Investigator Name
Miguel Piris Villaespesa
Principal Investigator Email
mpirisv@gmail.com
Contact Person Name
Miguel Piris Villaespesa
Contact Person Email
mpirisv@gmail.com
Site Name
Hospital Virgen Del Valle
Department Name
Hematology
Principal Investigator Name
Ivan Alvarez-Twose
Principal Investigator Email
ivana@sescam.jccm.es
Contact Person Name
Ivan Alvarez-Twose
Contact Person Email
ivana@sescam.jccm.es
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Principal Investigator Name
Helena Pomares Marin
Principal Investigator Email
hpomares@iconcologia.net
Contact Person Name
Helena Pomares Marin
Contact Person Email
hpomares@iconcologia.net
Site Name
Hospital Del Mar
Department Name
Hematology
Principal Investigator Name
Alicia Senin Magan
Principal Investigator Email
msenin@hmar.cat
Contact Person Name
Alicia Senin Magan
Contact Person Email
msenin@hmar.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Principal Investigator Name
Rosa Ayala Diaz
Principal Investigator Email
rosam.ayala@salud.madrid.org
Contact Person Name
Rosa Ayala Diaz
Contact Person Email
rosam.ayala@salud.madrid.org
Site Name
Hospital Quironsalud Zaragoza
Department Name
Hematology
Principal Investigator Name
Pilar Giraldo
Principal Investigator Email
giraldocastellano@gmail.com
Contact Person Name
Pilar Giraldo
Contact Person Email
giraldocastellano@gmail.com

Sponsor

Primary sponsor

Full Name
Telios Pharma Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Medpace Inc.
Responsibilities
sponsorDuties codes: 1,12,2,5 (as listed in CTIS record)
Name
Ppd Inc.
Responsibilities
sponsorDuties code: 4 (as listed in CTIS record)
Name
Suvoda LLC
Responsibilities
sponsorDuties code: 3 (as listed in CTIS record)

Third parties

  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"central ultrasound vendor, ePRO (sponsorDuties entries include code 15 with value 'central ultrasound vendor, ePRO'; additional duty codes present without textual value).","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"LabConnect GmbH","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Telios Pharma Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Aperio Clinical Outcomes LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"France","full_name":"KCAS Bio","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient travel reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Unity Health St. Michael’s Hospital","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medpace Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labconnect LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Australia","full_name":"Crux Biolabs Pty Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
TL-895
Active Substance
1-4-{[6-AMINO-5-(4-PHENOXY-PHENYL)-PYRIMIDIN-4-YLAMINO]-METHYL}-4-FLUORO-PIPERIDIN-1-YL)-PROPENONE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
300 mg/Kg (maxDailyDoseAmount as listed)
Investigational Product Name
TL-895 matching placebo
Modality
Other

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