Psoriatic ArthritisPhase 2NCT03320876
An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.
A Phase 2 study testing filgotinib in people with Psoriatic Arthritis, run by Lakefront Biotherapeutics NV at 25 sites in 7 countries.
Trial summary
This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects with moderately to severely active PsA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- filgotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 25 sitesin 7 countries
- Study dates
- 26 Jul 2017to 30 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
25 sites in 7 countries.
25 sites in 7 countries
Ukraine9 sites
CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
Kharkiv
CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
Kiev
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
Kyiv
CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
Lviv
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
Poltava
CI of TRC
Ternopil
M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
Vinnytsia
MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
Vinnytsia
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy
Vinnytsia
Bulgaria4 sites
UMHAT "Kaspela", EOOD
Plovdiv
MHAT - Ruse, AD
Rousse
UMHAT "SofiaMed", OOD, Block 1
Sofia
UMHAT "Sv. Ivan Rilski", EAD
Sofia
Poland4 sites
Twoja Przychodnia-Centrum Medyczne Nowa Sol
Nowa Sól
Ai Centrum Medyczne sp. z o.o. sp.k.
Poznan
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
Torun
Centrum Medyczne AMED, Warszawa Targowek
Warsaw
Estonia3 sites
Center for Clinical and Basic Research
Tallinn
North Estonia Medical Centre Foundation
Tallinn
OÜ Innomedica
Tallinn
Spain2 sites
Hospital Universitario de Fuenlabrada, Servicio de Reumatologia
Fuenlabrada
Hospital Infanta Luisa, Servicio de Reumatologia
Seville
About this study
Official title: A Multicenter, Open-label, Long-term Extension Safety and Efficacy Study of Filgotinib Treatment in Subjects With Moderately to Severely Active Psoriatic Arthritis.
This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects with moderately to severely active PsA. It is estimated that approximately 105 subjects will be rolled-over after they have completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224. Subjects will be administered filgotinib in this study until filgotinib is registered for PsA or until Week 304, whichever occurs first. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment.
- Conditions
- Psoriatic Arthritis
- Being tested
- filgotinib
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgotinibDrug
one filgotinib oral tablet once daily.
| Study group | Role | What they receive |
|---|---|---|
| filgotinib | Experimental | Not described Receives: Drug: filgotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the proportion of subjects with adverse events
To asses safety and tolerability of filgotinib.
Measured: Between entry visit and 4 weeks after the last dose.
Secondary outcomes (28)
Proportion of subjects achieving minimal disease activity (MDA)
To assess the effect of filgotinib on MDA in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response
To assess the effect of filgotinib on PsA as assessed by ACR20 in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects achieving ACR50 response
To assess the effect of filgotinib on PsA as assessed by ACR50 in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects achieving ACR70 response
To assess the effect of filgotinib on PsA as assessed by ACR70 in PsA patients
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA, i.e. PASDAS ≤ 3.2)
To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with PASDAS Very Low Disease Activity (VLDA) (i.e. PASDAS ≤1.9)
To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Percentage of patients subjects with PASDAS LDA (i.e. PASDAS ≤3.2)
To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Percentage of patients subjects with PASDAS VLDA (i.e. PASDAS ≤1.9)
To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)
To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with DAPSA remission/LDA (DAPSA ≤14)
To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with DAPSA remission (DAPSA ≤4)
To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in Psoriasis Area and Severity Index (PASI)
To assess the effect of filgotinib on PASI in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with PASI50
To assess the effect of filgotinib on PASI50 in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with PASI75
To assess the effect of filgotinib on PASI75 in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with PASI90
To assess the effect of filgotinib on PASI90 in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with PASI100
To assess the effect of filgotinib on PASI100 in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in Physician's global assessment of psoriasis
To assess the affect of filgotinib on Physician's global assessment of psoriasis in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in Patient's Global Assessment of psoriasis
To assess the affect of filgotinib on patient's global assessment of psoriasis in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in modified Nail Psoriasis Area and Severity Index (mNAPSI)
To assess the effect of filgotinib on mNAPSI in PsA patients assessment of psoriasis in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in pruritis numeric rating scale (NRS)
To assess the effect of filgotinib on NRS in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects achieving a pruritis numeric rating scale (NRS) response(improvement in pruritus NRS score of ≥3)
To assess the effect of filgotinib on NRS in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index
To assess the effect of filgotinib on SPARCC enthesitis index in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in Leeds Dactylitis Index (LDI)
To assess the effect of filgotinib on Dactilytis in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
To assess the effect of filgotinib on physical function in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue scale)
To assess the effect of filgotinib on FACIT-Fatigue scale in PsA patients.
Measured: W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
Change from core baseline in 36-item Short-Form Health Survey (SF-36)
To assess the effect of filgotinib on SF-36 in PsA patients
Measured: W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
Change from core baseline in Psoriatic Arthritis Impact of Disease Questionnaire (PsAID).
To assess the effect of filgotinib on PsAID in PsA patients.
Measured: W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
Change from core baseline in individual components of the ACR response of improvement in multiple disease assessment criteria
To assess the effect of filgotinib on signs and symptoms of peripheral arthritis and physical function in PsA patients.
Measured: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start26 Jul 2017
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: development program for filgotinib for participants with psoriatic arthritis has been stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vijay Rajendran, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320876
- Sponsor's protocol ID
- GLPG0634-CL-225
- Other IDs
- 2017-000545-52, 2017
- Status last verified
- Apr 2022
- First submitted
- 20 Oct 2017
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Long-term Extension Safety and Efficacy Study of Filgotinib Treatment in Subjects With Moderately to Severely Active Psoriatic Arthritis.
- ClinicalTrials.gov ID
- NCT03320876
- Acronym / sponsor ID
- GLPG0634-CL-225
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: development program for filgotinib for participants with psoriatic arthritis has been stopped
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects with moderately to severely active PsA. It is estimated that approximately 105 subjects will be rolled-over after they have completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224. Subjects will be administered filgotinib in this study until filgotinib is registered for PsA or until Week 304, whichever occurs first. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| filgotinib | Experimental | Drug: filgotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgotinibone filgotinib oral tablet once daily. | Drug | filgotinib |
Primary outcome
Change in the proportion of subjects with adverse events
Time frame: Between entry visit and 4 weeks after the last dose.
To asses safety and tolerability of filgotinib.
28 secondary outcomes
Proportion of subjects achieving minimal disease activity (MDA)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects achieving ACR50 response
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects achieving ACR70 response
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA, i.e. PASDAS ≤ 3.2)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with PASDAS Very Low Disease Activity (VLDA) (i.e. PASDAS ≤1.9)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Percentage of patients subjects with PASDAS LDA (i.e. PASDAS ≤3.2)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Percentage of patients subjects with PASDAS VLDA (i.e. PASDAS ≤1.9)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with DAPSA remission/LDA (DAPSA ≤14)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with DAPSA remission (DAPSA ≤4)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in Psoriasis Area and Severity Index (PASI)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with PASI50
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with PASI75
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with PASI90
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects with PASI100
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in Physician's global assessment of psoriasis
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in Patient's Global Assessment of psoriasis
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in modified Nail Psoriasis Area and Severity Index (mNAPSI)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in pruritis numeric rating scale (NRS)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Proportion of subjects achieving a pruritis numeric rating scale (NRS) response(improvement in pruritus NRS score of ≥3)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in Leeds Dactylitis Index (LDI)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from core baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Change from baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue scale)
Time frame: W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
Change from core baseline in 36-item Short-Form Health Survey (SF-36)
Time frame: W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
Change from core baseline in Psoriatic Arthritis Impact of Disease Questionnaire (PsAID).
Time frame: W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
Change from core baseline in individual components of the ACR response of improvement in multiple disease assessment criteria
Time frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Results and safety
The study was stopped early (reason given: development program for filgotinib for participants with psoriatic arthritis has been stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Psoriatic Arthritis
RecruitingPhase 3
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
Enrolling by invitation
Combined High-Intensity Aerobic Training and Resistance Training in Psoriatic Arthritis
Psoriatic Arthritis
Not yet recruiting
Definition of Novel Optoacoustic Biomarkers of Psoriasis and Psoriatic Arthritis
Psoriasis (PsO), Psoriasis Arthritis
RecruitingObservational study
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Rheumatic Joint Disease
Active, not recruitingPhase 2
Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)
Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay Rajendran, MD study director
Lakefront Biotherapeutics NV
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgotinib in people with Psoriatic Arthritis, run by Lakefront Biotherapeutics NV at 25 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Ukraine, Bulgaria, Poland, Estonia, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: development program for filgotinib for participants with psoriatic arthritis has been stopped). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the proportion of subjects with adverse events (time frame: Between entry visit and 4 weeks after the last dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.