Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
308
Countries
9
Sites
38
Indolent Systemic Mastocytosis
Part A: Cohorts 1-4: To determine the recommended phase 2 dose and schedule of TL-895 in each cohort. Part A: Cohort 5: To determine the recommended TL-895 dosing regimen(s). Part A: Cohort 6: To determine the recommended phase 3 dose of TL-895. Part B: Cohorts 1-4: Improvement in Total Symptom Score at Week 24 Part B:…
Key facts
- Sponsor
- Telios Pharma Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 7 Apr 2021 → ongoing
- Decision date (initial)
- 2024-07-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Telios Pharma, Inc.
External identifiers
- EU CT number
- 2024-514467-26-00
- EudraCT number
- 2020-002393-27
- WHO UTN
- U1111-1308-6577
- ClinicalTrials.gov
- NCT04655118
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacodynamic, Therapy, Efficacy, Safety
Part A: Cohorts 1-4: To determine the recommended phase 2 dose and schedule of TL-895 in each cohort.
Part A: Cohort 5: To determine the recommended TL-895 dosing regimen(s).
Part A: Cohort 6: To determine the recommended phase 3 dose of TL-895.
Part B: Cohorts 1-4: Improvement in Total Symptom Score at Week 24
Part B: Cohort 5: To assess changes in ISM symptoms after treatment with TL-895.
Part B Cohort 6: To assess changes in MCAS symptoms after treatment with TL-895.
Part C: Cohort 5: To compare changes in ISM symptoms after treatment with TL-895 vs placebo.
Secondary objectives 31
- 1. Part A Cohorts 1-4: To determine the Spleen Volume Reduction (SVR) rate of each arm of Cohorts 1-3 at Week 24
- 2. Part A Cohorts 1-4: Improvement in Total Symptom Score (TSS) in each arm of Cohorts 1-3 at Week 24
- 3. Part A Cohorts 1-4:To characterize the pharmacokinetic (PK) profile of TL-895
- 9. Part A Cohort 5: To compare changes in ISM symptoms after treatment with TL-895
- 10. Part A Cohort 5: To compare time to reduction in TSS after treatment with TL-895
- 11. Part A Cohort 5:To determine the effects of TL-895 on quality of life
- 12. Part A Cohort 5: To characterize the PK profile of TL-895 in ISM
- 4. Part B Cohorts 1-4: To determine the platelet response rate
- 5. Part B Cohorts 1-4: To determine the duration of platelet response
- 6. Part B Cohorts 1-4: To determine the incidence of platelet transfusion
- 7. Part B Cohorts 1-4: To determine the incidence of bleeding events
- 8. Part B Cohorts 1-4: To determine the SVR rate at Week 24
- 14. Part B Cohort 5: To assess additional changes in ISM and supplemental symptoms after treatment with TL-895
- 15. Part B Cohort 5: To assess time to TSS response after treatment with TL-895
- 16. Part B Cohort 5: To assess duration of TSS response after treatment with TL-895
- 17. Part B Cohort 5: To assess time to best reduction in TSS after treatment with TL-895
- 23. Part A Cohort 6: To compare changes in MCAS symptoms after treatment with TL-895
- 27. Part A Cohort 6: To compare the safety and tolerability of TL-895 vs placebo
- 25. Part A Cohort 6: To assess the effects of TL- 895 on quality of life
- 26. Part A Cohort 6: To characterize the PK profile of TL-895 in MCAS
- 28. Part B Cohort 6: To assess changes in MCAS symptoms after treatment with TL-895
- 13. Part A Cohort 5: To compare the safety and tolerability of TL-895 vs placebo
- 29. Part B Cohort 6: To assess time to reduction in TSS after treatment with TL-895
- 30. Part B Cohort 6: To assess the effects of TL- 895 on quality of life
- 31. Part B Cohort 6: To characterize the PK profile of TL-895 in MCAS
- 24. Part A Cohort 6: To compare time to reduction in TSS after treatment with TL-895
- 18. Part C Cohort 5: To compare the proportion of subjects with ISM-TSAF TSS response after treatment with TL-895 vs placebo
- 19. Part C Cohort 5: To compare additional changes in ISM and supplemental symptoms after treatment with TL-895 vs placebo
- 20. Part C Cohort 5: To compare time to TSS response after treatment with TL-895 vs placebo
- 21. Part C Cohort 5: To compare duration of TSS response after treatment with TL-895 vs placebo
- 22. Part C Cohort 5: To compare the best reduction in ISM and SISM after treatment with TL-895 vs placebo
Conditions and MedDRA coding
Indolent Systemic Mastocytosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10056452 | Indolent systemic mastocytosis | 10005329 |
Study design 6 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Cohort 1 Myelofibrosis
|
Not Applicable | None | ||
| 2 | Cohort 2 Myelofibrosis
|
Not Applicable | None | ||
| 3 | Cohort 3 Myelofibrosis
|
Not Applicable | None | ||
| 4 | Cohort 4 Myelofibrosis
|
Not Applicable | None | ||
| 5 | Cohort 5 Indolent Systemic Mastocytosis
|
Randomised Controlled | Double | [{"id":183425,"code":1,"name":"Subject"},{"id":183426,"code":2,"name":"Investigator"},{"id":183424,"code":5,"name":"Carer"}] | |
| 6 | Cohort 6 Mast Cell Activation Syndrome
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 13
- Cohorts 1-6: Adults ≥18 years of age
- 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
- Cohorts 1-4: High-risk, intermediate-2 risk, or intermediate-1 risk, defined by DIPSS
- Cohorts 1-6: Adequate hematologic, hepatic, and renal functions
- 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
- Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and < 50 x 10^9/L
- Cohort 5: Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results
- Cohort 5: Subject must have moderate-to-severe symptoms
- Cohort 6: Confirmed diagnosis of MCAS as defined by Working Group diagnostic criteria
- Cohort 4 only: Ineligibility for JAKi treatment with a platelet count of ≥ 15 and < 25x10^9/L
- Cohort 6: Moderate-to-severe chronic MCAS symptoms
- Cohort 6: Subject must have failed to achieve symptom control for one or more baseline chronic symptoms
- Cohort 6: The subject’s symptomatic MCAS therapies must be stable
Exclusion criteria 4
- Cohorts 1-4: Prior treatment with JAKi within 28 days prior to first study treatment
- Cohorts 1-4: Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
- Cohort 5: Diagnosis with another myeloid disorder
- Cohort 6: A current diagnosis of cutaneous or systemic mastocytosis as defined by WHO criteria
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 5
- 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 endpoints 3
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD11336838 · Product
- Active substance
- 1-4-6-AMINO-5-4-PHENOXY-PHENYL-PYRIMIDIN-4-YLAMINO-METHYL-4-FLUORO-PIPERIDIN-1-YL-PROPENONE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg/Kg milligram(s)/kilogram
- Max total dose
- 547500 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- TELIOS PHARMA INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11336839 · Product
- Active substance
- 1-4-6-AMINO-5-4-PHENOXY-PHENYL-PYRIMIDIN-4-YLAMINO-METHYL-4-FLUORO-PIPERIDIN-1-YL-PROPENONE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg/Kg milligram(s)/kilogram
- Max total dose
- 547500 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- TELIOS PHARMA INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11336841 · Product
- Active substance
- 1-4-6-AMINO-5-4-PHENOXY-PHENYL-PYRIMIDIN-4-YLAMINO-METHYL-4-FLUORO-PIPERIDIN-1-YL-PROPENONE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg/Kg milligram(s)/kilogram
- Max total dose
- 547500 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- TELIOS PHARMA INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11336840 · Product
- Active substance
- 1-4-6-AMINO-5-4-PHENOXY-PHENYL-PYRIMIDIN-4-YLAMINO-METHYL-4-FLUORO-PIPERIDIN-1-YL-PROPENONE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg/Kg milligram(s)/kilogram
- Max total dose
- 547500 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- TELIOS PHARMA INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11336842 · Product
- Active substance
- 1-4-6-AMINO-5-4-PHENOXY-PHENYL-PYRIMIDIN-4-YLAMINO-METHYL-4-FLUORO-PIPERIDIN-1-YL-PROPENONE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg/Kg milligram(s)/kilogram
- Max total dose
- 547500 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- TELIOS PHARMA INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Telios Pharma Inc.
- Sponsor organisation
- Telios Pharma Inc.
- Address
- 275 Shoreline Drive Suite 325
- City
- Redwood City
- Postcode
- 94065-1407
- Country
- United States
Scientific contact point
- Organisation
- Telios Pharma Inc.
- Contact name
- Regulatory Affairs
Public contact point
- Organisation
- Telios Pharma Inc.
- Contact name
- Regulatory Affairs
Third parties 16
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other, Data management |
| LabConnect GmbH ORG-100047696
|
Cologne, Germany | Laboratory analysis |
| Telios Pharma Inc. ORG-100026575
|
Redwood City, United States | Laboratory analysis |
| Aperio Clinical Outcomes LLC ORG-100046387
|
Durham, United States | E-data capture |
| EPL Pathology Archives LLC ORG-100042096
|
Leesburg, United States | Laboratory analysis |
| Arup Laboratories Inc. ORG-100041750
|
Salt Lake City, United States | Laboratory analysis |
| KCAS Bio ORG-100042693
|
Lyon, France | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Ppd Inc. ORG-100018960
|
Middleton, United States | Laboratory analysis |
| Unity Health St. Michael’s Hospital ORL-000016382
|
Toronto, Canada | Laboratory analysis |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Medpace Inc. ORG-100026760
|
Cincinnati, United States | On site monitoring, Code 12, Code 2, Code 5 |
| Labconnect LLC ORG-100042800
|
Johnson City, United States | Laboratory analysis |
| Primevigilance Limited ORG-100027742
|
Guildford, United Kingdom | Code 8 |
| Crux Biolabs Pty Limited ORG-100047293
|
Bayswater, Australia | Laboratory analysis |
| Fisher Clinical Services GmbH ORG-100017323
|
Weil Am Rhein, Germany | Code 14 |
Locations
9 EU/EEA countries · 38 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 24 | 3 |
| Bulgaria | Ended | 13 | 1 |
| France | Ended | 13 | 2 |
| Germany | Ongoing, recruiting | 24 | 8 |
| Italy | Ongoing, recruiting | 34 | 11 |
| Netherlands | Authorised, recruitment pending | 14 | 1 |
| Norway | Authorised, recruitment pending | 24 | 1 |
| Poland | Ongoing, recruitment ended | 18 | 4 |
| Spain | Ongoing, recruiting | 24 | 7 |
| Rest of world
Switzerland, Australia, Canada, Korea, Republic of, Taiwan, United Kingdom, United States
|
— | 120 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Hematologie voor volwassenen, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
Immunologie, allergologie en reumatologie, Drie Eikenstraat 655, 2650, Edegem
Centre hospitalier universitaire de Liege
Hematologie clinique, Avenue De L'hopital 1, 4000, Liege
Centre Hospitalier Le Mans
onco-hematology, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Universitaire De Nice
hematology, 151 Route De Saint Antoine, 06200, Nice
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medizinische Klinik und Poliklinik 1, Bereich Hämatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Halle (Saale) AöR
Klinik für Innere Medizin IV- Hämatologie/Onkologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
University Medical Center Hamburg-Eppendorf
Department II, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Jena KöR
Klinik für Innere Medizin II- Hämatologie und Internistische Onkologie, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Aachen AöR
Hematology, Oncology, Pauwelsstrasse 30, 52074, Aachen
Charite Universitaetsmedizin Berlin KöR
Campus Benjamin Franklin, Institute of Allergology, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Schleswig-Holstein AöR
Hämatologie und Onkologie, Ratzeburger Allee 160, 23538, Luebeck
Universitaetsklinikum Mannheim GmbH
(Internal Medicine, Haematology, Oncology, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Fondazione IRCCS Policlinico San Matteo
SC ematologia I, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
DIPARTIMENTO MALATTIE ONCOLOGICHE ED EMATOLOGICHE, Via Pietro Albertoni 15, 40138, Bologna
Azienda Unita Sanitaria Locale Della Romagna
Dipartimento Di Onco-Ematologia, Viale Vincenzo Randi 5, 48121, Ravenna
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
UO di Ematologia, Via Francesco Sforza 35, 20122, Milan
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Dipartimento di Ematologia, Oncologia e Dermatologia, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliera di Padova
UOSD Allergologia, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliero Universitaria Careggi
SOD Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
UO di Ematologia con T.M.O., Via Santa Sofia 78, 95123, Catania
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Divisione di Ematologia, Viale Europa, 89133, Reggio Calabria
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Dipartimento medico specialistico e oncologico, Corso Giuseppe Mazzini 18, 28100, Novara
ASST Grande Ospedale Metropolitano Niguarda
Divisione di Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Internal Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Klinika Hematologii, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Uniwersyteckie Centrum Kliniczne
Klinika Alergologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddzial Kliniczny Hematologii, Ul. Mikolaja Kopernika 17, 31-501, Cracow
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Nowotworow Krwii i Transplantacji Szpiku, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Hospital Quironsalud Zaragoza
Hematology, Paseo Renovales S/n, 50006, Zaragoza
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Germans Trias I Pujol
Hematology, Carretera Canyet 1a Planta, 08916, Badalona
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Virgen Del Valle
Hematology, Carretera De Cobisa Sn, 45004, Toledo
Hospital Del Mar
Hematology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2021-05-06 | 2023-01-12 | |||
| Bulgaria | 2021-04-07 | 2025-04-02 | 2022-02-14 | 2023-06-12 | |
| France | 2021-04-20 | 2024-10-03 | 2021-05-25 | 2022-06-19 | |
| Germany | 2021-07-30 | 2021-08-10 | |||
| Italy | 2021-05-25 | 2021-06-09 | |||
| Poland | 2021-08-11 | 2021-10-06 | 2025-08-11 | ||
| Spain | 2021-04-12 | 2021-07-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 73 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol clarification memo_2024-514467-26_Telios_redacted | NA |
| Protocol (for publication) | D1_Protocol memo for BU_2024-514467-26_Telios_redacted | N/A |
| Protocol (for publication) | D1_Protocol_2024-514467-26_Telios_redacted | 11.1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire Statement_Telios | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BE_Telios | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BG_Telios_blank | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DE_Telios | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES_Telios | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT_Telios | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_NL_Telios | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NO_Telios | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL_Telios | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data Privacy ICF_Telios | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research Main Data ICF ICF_Telios | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research Skin Biopsy ICF_Telios | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Sample_DU_Telios_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Sample_EN_Telios_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Sample_FR_Telios_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Sample_Telios_BG_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Sample_Telios_EN_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Sample_Telios_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic_Telios_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Cohort 5 Part B_Telios_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Cohort 5 Part C_Telios_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF ISM Part A_Telios_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF ISM Part B_Telios_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF ISM Part C_Telios_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Telios_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ISM Cohort 5 Part A ICF_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ISM Cohort 5 Part B ICF_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ISM Cohort 5 Part C ICF_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ISM_Part A _Telios_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ISM_Part B_Telios_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ISM_Part C_Telios_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Cohort 1-4_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Cohort 5 Part A_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part A_DU_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part A_EN_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part A_FR_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part B_DU_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part B_EN_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part B_FR_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part C_DU_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part C_EN_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part C_FR_Telios_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Telios_BG_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Telios_EN_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Skin Biopsy ICF_Telios_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Skin Photograph ICF_Telios_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy ICF_Telios_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Telios | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_DU_Telios | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_EN_Telios | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_FR_Telios | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Telios_BG | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Telios_EN | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Telios_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Telios_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Telios_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Telios_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_cc03 ClinCard Cardholder_Telios | 10 |
| Synopsis of the protocol (for publication) | D1_Lay synopsis_DUT_2024-514467-26_Telios_redacted | 11.1 |
| Synopsis of the protocol (for publication) | D1_Lay synopsis_ENG_2024-514467-26_Telios_redacted | 11.1 |
| Synopsis of the protocol (for publication) | D1_Lay synopsis_ITA_2024-514467-26_Telios_redacted | 11.1 |
| Synopsis of the protocol (for publication) | D1_Lay synopsis_NO_2024-514467-26_Telios_redacted | 11.1 |
| Synopsis of the protocol (for publication) | D1_Lay synopsis_POL_2024-514467-26_Telios_redacted | 11.1 |
| Synopsis of the protocol (for publication) | D1_Lay synopsis_SPA_2024-514467-26_Telios_redacted | 11.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DUT_2024-514467-26_Telios_redacted | 11.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2024-514467-26_Telios_redacted | 11.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FRE_2024-514467-26_Telios_redacted | 11.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GER_2024-514467-26_Telios_redacted | 11.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ITA_2024-514467-26_Telios_redacted | 11.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_POL_2024-514467-26_Telios_redacted | 11.1 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-13 | Spain | Acceptable with conditions 2024-07-11
|
2024-07-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-06 | Spain | Acceptable with conditions 2024-07-11
|
2024-09-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-31 | Spain | Acceptable 2025-02-12
|
2025-02-12 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-27 | Acceptable 2025-02-12
|
2025-03-27 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-05-19 | Acceptable 2025-02-12
|
2025-05-19 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-06-02 | Spain | Acceptable 2025-02-12
|
2025-06-02 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-06-06 | Acceptable 2025-02-12
|
2025-06-06 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-09-29 | Acceptable 2025-02-12
|
2025-09-29 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-16 | Spain | Acceptable 2025-11-26
|
2025-12-01 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-12-23 | Acceptable 2025-11-26
|
2025-12-23 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-12 | Spain | Acceptable | 2026-02-10 |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2026-01-21 | Acceptable 2025-11-26
|
2026-03-19 | |
| 13 | SUBSEQUENT ADDITION OF MSC | APP-13 | 2026-01-30 | Acceptable 2025-11-26
|
2026-04-24 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-04-28 | Spain | Acceptable 2025-11-26
|
2026-04-28 |