Scientific transparency
Please note: indications outlined here are currently under development and have not been approved by regulatory authorities. Any use of the product for these indications would be considered off-label.
We are committed to integrity and transparency as we carry out clinical research
As such all our clinical trials and real-world evidence studies are published in clinical trials.gov and whenever applicable, also to the HMA–EMA Catalogue of Real‑World Data (RWD) Studies.
By providing access to clinical trial protocol information and summary results, we seek to offer clinical research transparency that will spur scientific innovation, improve medical care and build public trust.
More information on ongoing Alfasigma sponsored clinical research can be found in their dedicated pages within these databases.
Please note: indications outlined here are currently under development and have not been approved by regulatory authorities. Any use of the product for these indications would be considered off-label.
| Asset | Therapeutic area | Study Name | Study | Short Description | ClinicalTrials.gov ID |
| Filgotinib | Rheumatology | FILOSOPHY | Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis | An observational study to describe the effectiveness, safety, and patient-reported outcomes in patients with moderate to severe active rheumatoid arthritis (RA) receiving filgotinib in real-world setting. | NCT04871919 |
| Filgotinib | Rheumatology | PARROTFISH | Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France | An observational study to describe the effectiveness, safety, and patient-reported outcomes (PROs) in participants with moderate to severe active rheumatoid arthritis (RA) in France receiving filgotinib in real-world setting. | NCT05323591 |
| Filgotinib | Rheumatology | FINCH4 | A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis | The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA). | NCT03025308 |
| Filgotinib | Gastroenterology | SELECTION LTE | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis | The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC). | NCT02914535 |
| Filgotinib | Gastroenterology | GALOCEAN | A prospective, non-interventional, multi-country cohort study of the effectiveness and safety of filgotinib in adult patients with moderately to severely active ulcerative colitis | To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting. | NCT05817942 |
| Filgotinib | Gastroenterology | GALAPEDUCA | A multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of filgotinib, with single arm induction and maintenance, in pediatric subjects (8 to <18 years of age) with moderately to severely active ulcerative colitis | The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years. Approximately 80 subjects from 8 to <18 years of age with moderately to severely active UC, including a minimum of 8 subjects from 8 to <12 years of age, will be enrolled in this study. During the study, eligible subjects will take the investigational product (IP) on-site at Week 4, Week 10, and Week 22 (in the morning; with or without food). On all other days, subjects will take IP at home (in the morning; with or without food). Subjects who do not achieve mMCS remission and/or MCS response at Week 10 will continue with induction treatment until Week 22. Subjects who do not achieve PUCAI remission at Week 22 will be permanently discontinued from the study. Subjects will all receive a filgotinib dose targeting the same systemic exposure as that observed in adults with UC treated with 200 mg q.d. | NCT06865417 |
| Filgotinib | Immunology | OLINGUITO | A Phase 3 randomized, placebo-controlled, double-blind, parallel-group program to evaluate efficacy and safety of filgotinib in adult subjects with active axial spondyloarthritis | This study is comparing 200 milligrams (mg) of filgotinib a day with a placebo to see if filgotinib helps to treat Axial Spondyloarthritis (axSpA) and is safe to use. The study will also be comparing 200 mg with 100 mg filgotinib a day to see if the lower dose also helps to treat axSpA. | NCT05785611 |
| Filgotinib | Immunology | SCALESIA | An open-label, multiple dose, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of filgotinib in children and adolescents from 8 to less than 18 years of age with juvenile idiopathic arthritis | A Study to evaluate the pharmacokinetics, safety, and tolerability in paediatric population for treating juvenile idiopathic arthritis (JIA). | NCT06222034 |
| Filgotinib | Immunology | GALAHOPPER | Multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of filgotinib in children and adolescents from 8 years to less than 18 years of age with polyarticular-course juvenile idiopathic arthritis (pJIA) | This is a multicenter Phase 3, open-label, single-arm study to evaluate the safety, tolerability, PK, and efficacy of orally administered filgotinib for up to 18 weeks. | NCT07554495 |
| Filgotinib | Immunology | OLE JIA | Open-label extension (OLE), multiple dose study to evaluate safety, tolerability, and efficacy of filgotinib in children and adolescents from 8 years to less than 18 years of age with juvenile idiopathic arthritis (JIA) | This OLE study is designed to evaluate long-term safety, tolerability, and efficacy of filgotinib in patients with polyarticular or systemic juvenile idiopathic arthritis (pJIA-sJIA) who have completed the treatment period/prolonged treatment period of the parent studies and demonstrated clinical benefit defined as control of disease activity through improvement in signs and symptoms as per Investigator judgement. | NCT07553182 |
At Alfasigma, we believe that transparency in clinical trials is essential to advance science and medicine
Alfasigma is committed to Clinical Trial Data Sharing according to the EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing.
Access to clinical trial data will be provided in full compliance with all applicable laws and regulatory guidance to safeguard commercially confidential information and patient privacy.
1. How to make a data sharing request
All data sharing requests are funnelled through Vivli, an Independent Data Sharing Platform: Vivli - Center for Global Clinical Research Data
The studies eligible for data sharing are listed and searchable on the Vivli Platform.
External researchers should enter their request in Vivli. If approved by Alfasigma Clinical Trial Data Sharing team, the requester will need to sign a Data Use Agreement and the anonymised data will be shared in the Vivli secure research environment.
2. Studies listed for sharing
We will provide access to anonymised, patient-level and study-level clinical trial data and other information (such as protocols and clinical study reports) from in-scope Phase 1-4 clinical studies for medicinal products that have received an initial marketing authorisation, on approved indications or on indications where the drug development programme was terminated.
3. When studies are available for sharing
Studies are considered to be available if all the following conditions are met:
- Study is completed as per protocol.
- Summary results have been published on ClinicalTrials.gov (CT.gov) and/or the European Union Clinical Trials Register (EU-CTR).
- Primary manuscript disclosing study’s primary endpoints, key secondary endpoints, and safety data is published.
After the first European Medicines Agency (EMA) and/or US Food and Drug Administration (FDA) approval – not applicable if development programme was terminated.
4. Data Request Review Process
Consistent with expectations of good scientific practice, researchers can request access to our studies by providing a research proposal with a commitment to publishing their findings. The research proposal is reviewed by Alfasigma Clinical Trial Data Sharing team and by the Vivli independent review panel.
5. What information will be provided
The following documents will be provided to the Researcher:
- Study Protocol
- Study data package documentation including information on the dataset structure and data dictionaries
- Statistical Analysis Plan
- Anonymised/redacted Clinical Study Report (CSR)
- Anonymised individual patient data
Optional:
- Anonymisation Guidance
- Analytic code
- Analysis ready IPD data set
- Case report forms
6. Questions or enquiries
Questions can be sent to Alfasigma by means of the Vivli Enquiry process.
7. Anonymisation Standards
Risk-based approach (both qualitative and quantitative) to minimise risk of patient re-identification, derived from industry best practices (e.g., PhUSE, TransCelerate) and regulatory guidances from EMA and FDA. The overall aim is for a pragmatic balance, ensuring an acceptably low risk of re-identification whilst retaining data utility.
Alfasigma ensures that the results of clinical studies involving patients related to Alfasigma development programmes are submitted for publication to peer-reviewed scientific journals in a timely manner, irrespective of study outcome or the decision to discontinue clinical development of investigational medicines.
We require that all manuscripts resulting from Alfasigma funded research that are submitted to scientific journals are peer-reviewed and offer public availability via Open Access. This allows for a "barrier-free" way in which publications can be accessed online and for free, without subscription or pay-to-view requirement.