E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the long-term safety and tolerability of filgotinib in patients with psoriatic arthritis (PsA). |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the long-term efficacy of filgotinib in patients with PsA.
- To evaluate the long-term effects of filgotinib administration on disability, fatigue and quality of life in patients with PsA. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female subjects who are ≥18 years of age, having completed the 16 weeks of treatment in the qualifying core study GLPG0634-CL-224 and who may benefit from filgotinib long-term treatment according to the investigator’s judgment.
• Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to continue to use highly effective methods of contraception as described in the protocol.
• Able and willing to sign the informed consent form (ICF), as approved by the Independent Ethics Committee (IEC) and agree to the schedule of assessments. |
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E.4 | Principal exclusion criteria |
• Subjects who are deemed not to be benefitting from the study drug based upon lack of improvement or worsening of their symptoms. Local guidelines for subject treatment need to be followed.
• Persistent abnormal laboratory values associated with the use of the study drug (including and not limited to hematology, liver and renal function values), according to the investigator’s clinical judgment.
• Subjects who discontinued the qualifying core study GLPG0634-CL-224 due to safety or tolerability issues.
• Subjects who require immunization with live/live attenuated vaccine.
• Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than psoriatic arthritis, except for Sjögren’s syndrome.
• Subjects with symptoms suggestive of uncontrolled hypertension, congestive heart failure, uncontrolled diabetes, cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia or any other cardiovascular condition since the inclusion to the GLPG0634-CL-224 study.
• Subjects with symptoms suggestive of gastrointestinal tract ulceration and/or active diverticulitis since the inclusion to the GLPG0634-CL-224 study.
• Subjects with symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly since the inclusion to the GLPG0634-CL-224 study.
• Subjects with symptoms suggestive of malignancy since the inclusion to the GLPG0634-CL-224 study.
Reference is made to the protocol for a complete overview of the exclusion criteria. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of AEs, SAEs, and discontinuations due to AEs, as well as changes in laboratory results, ECGs, body weight and vital signs over time |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Various timepoints throughout the trial as specified in the protocol |
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E.5.2 | Secondary end point(s) |
• Signs and symptoms of PsA:
- Proportion of subjects achieving MDA.
- Proportion of subjects with PASDAS low disease activity (LDA, i.e.
PASDAS ≤ 3.2) and proportion of subjects with PASDAS VLDA (Very Low
Disease Activity, i.e. PASDAS ≤ 1.9).
• Signs and symptoms of peripheral arthritis:
- Proportion of subjects achieving ACR20, ACR50 and ACR70 response
rates.
- Percentage of patients with Psoriatic Arthritis Disease Activity Score
(PASDAS) low disease activity (LDA, i.e. PASDAS ≤3.2)
- Percentage of patients with PASDAS VLDA (Very Low Disease Activity,
i.e. PASDAS≤1.9)
- Change from core baseline in Disease Activity Index for Psoriatic
Arthritis (DAPSA)
- Proportion of subjects with DAPSA remission/LDA (DAPSA ≤ 14) and
proportion of subjects with DAPSA remission (DAPSA ≤ 4)
• Psoriasis in those subjects with psoriasis involving ≥3% Body Surface
Area (BSA), or with psoriatic nail involvement (only for mNAPSI), at core
baseline:
- Change from core baseline in PASI and proportions of subjects with
PASI50, PASI75, PASI90, and PASI100.
- Change from core baseline in Physician's Global Assessment of
psoriasis.
- Change from core baseline in Patient's Global Assessment of psoriasis.
- Change from core baseline in mNAPSI.
- Change from core baseline in pruritus NRS.
- Proportion of subjects achieving a pruritus NRS response
(improvement in pruritus NRS score of ≥3).
• Enthesitis in those subjects with enthesitis at core baseline:
- Change from core baseline in the SPARCC Enthesitis Index.
• Dactylitis in those subjects with dactylitis at core baseline:
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- Change from core baseline in LDI.
• Physical function:
- Change from core baseline in HAQ-DI.
• Fatigue and general quality of life:
- Change from core baseline in FACIT-Fatigue, SF-36, and PsAID scores.
• Signs and symptoms of peripheral arthritis and physical function:
- Change from core baseline in individual components of the ACR
response criteria |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At each on-site visit unless otherwise specified in the protocol |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Bulgaria |
Czech Republic |
Estonia |
Germany |
Poland |
Spain |
Ukraine |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 7 |