Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
646
Countries
1
Sites
3
Ulcerative Colitis (UC)
To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in UC
Key facts
- Sponsor
- Alfasigma S.p.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 12 Apr 2017 → ongoing
- Decision date (initial)
- 2024-09-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Alfasigma S.p.A.
External identifiers
- EU CT number
- 2024-516199-14-00
- EudraCT number
- 2016-002765-58
- ClinicalTrials.gov
- NCT02914535
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in UC
Secondary objectives 1
- To evaluate the effect of filgotinib on partial Mayo Clinic Score (MCS)
Conditions and MedDRA coding
Ulcerative Colitis (UC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10045365 | Ulcerative colitis | 10017947 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis
|
Randomised Controlled | Double | [{"id":179041,"code":2,"name":"Investigator"},{"id":179040,"code":3,"name":"Monitor"},{"id":179039,"code":1,"name":"Subject"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures associated with this trial
- Must have enrolled in Gilead-sponsored UC parent protocol GS-US-4183898 or any other Gilead/Galapagos-sponsored filgotinib treatment study in Ulcerative Colitis
- Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC
- Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
- Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the clinical study protocol
- Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
Exclusion criteria 7
- Subjects who are discontinued from a parent study for reasons other than disease worsening, or lack of response or remission; eg, subjects who discontinue for safety or tolerability issues are not eligible for the present study.
- Known hypersensitivity to the study drug
- Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or Sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol
- Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or future fertilization during the course of the study and for at least 30 days of the last dose of the study drug
- Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of study drug
- Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods
- Use of prohibited concomitant medications as outlined in the protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Safety, evaluated through AEs, clinical laboratory tests, and vital signs
Secondary endpoints 1
- To evaluate the effect of filgotinib on partial Mayo Clinic Score (MCS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Jyseleca 200 mg film-coated tablets
PRD9422638 · Product
- Active substance
- Filgotinib
- Substance synonyms
- G-146034
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200.00 mg milligram(s)
- Max total dose
- 470400.00 mg milligram(s)
- Max treatment duration
- 336 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA45 — -
- Marketing authorisation
- EU/1/20/1480/003
- MA holder
- GALAPAGOS
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Jyseleca 100 mg film-coated tablets
PRD9422607 · Product
- Active substance
- Filgotinib
- Substance synonyms
- G-146034
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100.00 mg milligram(s)
- Max total dose
- 235200.00 mg milligram(s)
- Max treatment duration
- 336 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA45 — -
- Marketing authorisation
- EU/1/20/1480/001
- MA holder
- GALAPAGOS
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Composition apart from the active substance otherwise to identical to IMP
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
Alfasigma S.p.A.
- Sponsor organisation
- Alfasigma S.p.A.
- Address
- Via Ragazzi Del '99 5
- City
- Bologna
- Postcode
- 40133
- Country
- Italy
Scientific contact point
- Organisation
- Alfasigma S.p.A.
- Contact name
- Alfasigma S.p.A.
Public contact point
- Organisation
- Alfasigma S.p.A.
- Contact name
- Alfasigma S.p.A.
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health Management Limited ORG-100040504
|
Reading, United Kingdom | Interactive response technologies (IRT) |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Indianapolis, United States | Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other, E-data capture |
| Icon Public Limited Company ORG-100042517
|
Dublin 18, Ireland | On site monitoring, Code 12, Code 2, Code 5 |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ongoing, recruitment ended | 26 | 3 |
| Rest of world
Hong Kong, Australia, Switzerland, New Zealand, Argentina, India, United States, Israel, South Africa, Malaysia, Canada, United Kingdom, Korea, Republic of, Georgia, Taiwan, Mexico, Ukraine, Serbia, Singapore, Russian Federation, Japan
|
— | 620 | — |
Investigational sites
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Központi Felnőtt Szakrendelő, Albert Florian Ut 5-7, 1097, Budapest IX
Gyoengyosi Bugat Pal Koerhaz
Endoszkópiai Laboratórium, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
University Of Debrecen
II. sz. Belgyógyászati Klinika, Gasztroenterológia, Nagyerdei Korut 98, 4032, Debrecen
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 |
|---|---|---|---|---|---|
| Hungary | 2017-04-12 | 2017-09-27 | 2020-03-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-516199-14-00_redacted | 12 |
| Recruitment arrangements (for publication) | K_HU_Recruitment Arrangements_Placeholder document | 1 |
| Subject information and informed consent form (for publication) | L1_HU_ICF_Main_Hungarian | 11.1 |
| Subject information and informed consent form (for publication) | L1_HU_SIS_Main_Hungarian_redacted | 11.1 |
| Subject information and informed consent form (for publication) | L2_HU_Other subject material_Emergency Patient Card_Hungarian | 3.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-23 | Hungary | Acceptable 2024-09-03
|
2024-09-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-20 | Hungary | Acceptable 2024-09-03
|
2024-12-20 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-16 | Hungary | Acceptable 2024-09-03
|
2025-01-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-11 | Hungary | Acceptable | 2025-10-22 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-31 | Hungary | Acceptable | 2026-03-31 |