Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
14
Countries
6
Sites
7
Myelofibrosis ; postlung transplant (BOS); chronic graft-versus-host disease
To provide continued treatment and evaluation of safety in participants who are receiving clinical benefit with an itacitinib-based therapy in an Incyte-sponsored clinical study.
Key facts
- Sponsor
- Incyte Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Aug 2023 → 4 May 2026
- Decision date (initial)
- 2023-05-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Incyte Corporation
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
To provide continued treatment and evaluation of safety in participants who are receiving clinical benefit with an itacitinib-based therapy in an Incyte-sponsored clinical study.
Conditions and MedDRA coding
Myelofibrosis ; postlung transplant (BOS); chronic graft-versus-host disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10066261 | Chronic graft versus host disease | 100000004870 |
| 23.0 | LLT | 10083303 | Bronchiolitis obliterans syndrome | 10038738 |
| 20.0 | PT | 10028537 | Myelofibrosis | 100000004864 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2018-001606-29 | GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease, GRAVITAS-309: Estudio en fase III de itacitinib o placebo en combinación con corticoesteroides como tratamiento inicial de la enfermedad de injerto contra huésped crónica (EICHc), Studio di fase 3 su itacitinib o placebo in combinazione con corticosteroidi come trattamento iniziale per la malattia cronica del trapianto contro l’ospite | |
| 2020-003123-42 | A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post–Polycythemia Vera Myelofibrosis or Post–Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy, Eine zweiteilige offene Studie der Phase 2 zur Sicherheit, Verträglichkeit und Wirksamkeit von Itacitinib mit sofortiger Wirkstofffreisetzung (IR) bei Patienten mit primärer Myelofibrose oder sekundärer Myelofibrose (Post-Polycythaemia-vera-Myelofibrose oder Post- Essentielle-Thrombozythämie-Myelofibrose), die zuvor eine Ruxolitinib- und/oder Fedratinib- Monotherapie erhalten haben, Estudio abierto de fase II de 2 partes de la seguridad, tolerabilidad y eficacia de la liberación inmediata de itacitinib en pacientes con mielofibrosis primaria o secundaria (mielofibrosis pospolicitemia vera o mielofibrosis postrombocitemia esencial) que han recibido ruxolitinib o fedratinib con anterioridad en monoterapia, Studio in aperto di fase 2, in 2 parti, sulla sicurezza, la tollerabilità e l’efficacia di itacitinib a rilascio immediato in pazienti affetti da mielofibrosi primaria o mielofibrosi secondaria (mielofibrosi post-policitemia vera o mielofibrosi post-trombocitemia essenziale) che hanno ricevuto precedente monoterapia con ruxolitinib e/o fedratinib | |
| 2019-004171-39 | An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB 39110)-based clinical study (parent protocol).
- Currently tolerating treatment as defined by the parent protocol.
- Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator.
- Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
- Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol.
- Willingness to avoid pregnancy or fathering children based on criteria in Section 5. l .
- Ability to comprehend and willingness to sign an ICF.
Exclusion criteria 4
- Able to access itacitinib therapy commercially.
- Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
- Pregnant or breastfeeding women.
- Any personal status that would prohibit clinical trial participation under local regulations.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Assessment of AEs and SAEs reported in participants continuing to receive itacitinib.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10018185 · Product
- Active substance
- Itacitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- INCYTE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMA/4237/2018
PRD1600053 · Product
- Active substance
- Itacitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- INCYTE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMA/4237/2018
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Incyte Corp.
- Sponsor organisation
- Incyte Corp.
- Address
- 1801 Augustine Cut Off
- City
- Wilmington
- Postcode
- 19803-4404
- Country
- United States
Scientific contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trial Information
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Syneos Health Netherlands B.V. ORG-100013861
|
Amsterdam, Netherlands | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 5, Data management, E-data capture |
| Syneos Health Hellas Single Member S.A. ORG-100043210
|
Vrilissia, Greece | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 5, Data management, E-data capture |
Locations
6 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 1 | 1 |
| Belgium | Ended | 1 | 1 |
| Germany | Ended | 4 | 2 |
| Greece | Ended | 1 | 1 |
| Italy | Ended | 3 | 1 |
| Spain | Ended | 2 | 1 |
| Rest of world
United States, Canada, Israel
|
— | 2 | — |
Investigational sites
Ordensklinikum Linz GmbH
Hämatologie mit stammzelltransplantation, Hämostatseologie und medizinische Onkologie, Fadingerstrasse 1, 4020, Linz
Martin-Luther-Universitaet Halle-Wittenberg
Department of Internal Medicine IV (Hematology and Oncology), Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
Universitaetsklinikum Mannheim GmbH
Department of Hematology and Oncology, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
University General Hospital Attikon
2nd Department of Internal Medicine, Rimini Street 1, 124 62, Athens
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Centro di Ematologia e Trapianti, Dipartimento di Medicina e Chirurgia, Largo Citta' D'ippocrate 1, 84131, Salerno
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 |
|---|---|---|---|---|---|
| Austria | 2023-08-29 | 2026-04-09 | 2023-08-29 | ||
| Belgium | 2023-09-20 | 2026-02-10 | 2023-09-20 | ||
| Germany | 2023-08-23 | 2026-05-04 | 2023-08-23 | ||
| Italy | 2023-08-24 | 2023-08-24 | |||
| Spain | 2023-09-07 | 2026-04-30 | 2023-09-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 42 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Cover page INCB39110-213 | 2 |
| Protocol (for publication) | D1_Cover page INCB39110-214 | 5 |
| Protocol (for publication) | D1_Cover page INCB39110-309 | 8 |
| Protocol (for publication) | D1_Protocol 2022-501661-47-00 GR_redacted | 3 |
| Protocol (for publication) | D1_Protocol 2022-501661-47-00_redacted | 3 |
| Protocol (for publication) | D1_Protocol amend COVID 19 appendix_2022-501661-47-00 | 2 |
| Recruitment arrangements (for publication) | K1_recruitment arragments_IT | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES | N/A |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main ICF_IT_Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_Informed consent procedure | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main PIS ICF_Germany_redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE_DUT_Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE_EN_Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE_FRE_Redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ES | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy and Birth_IT_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Germany | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BE_DUT | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BE_ENG | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BE_FRE | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_pregnant partner_ES | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICFs_Main ICF_Austria_redacted | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICFs_Pregnant Partner ICF_Austria | 1.1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP letter_IT | 1.1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information Material_Reimbursement Procedures_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information Material_Reimbursement Request Form_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Reminder Card | 1.1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Reminder Card | 1.1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Reminder Card_ES | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information Material_reminder card_IT | 1.1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing document_BE_DUT | 1 |
| Subject information and informed consent form (for publication) | L2_Patient facing document_BE_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Patient facing document_BE_FRE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE_2022-501661-47-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_2022-501661-47-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2022-501661-47-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2022-501661-47-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GR_2022-501661-47-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2022-501661-47-00 | 3 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-10 | Austria | Acceptable 2023-03-20
|
2023-05-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-06-16 | Acceptable | 2023-07-19 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-16 | Austria | Acceptable 2024-02-05
|
2024-02-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-30 | Austria | Acceptable 2024-11-18
|
2024-11-20 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-10 | Austria | Acceptable 2024-11-18
|
2025-09-10 |