A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis

Axial Spondyloarthritis Clinical Trial

— OLINGUITO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05785611
• Other study ID #: GLPG0634-CL-336
• Secondary ID: 2022-501354-10-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 5, 2023
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 495
• Est. completion date: July 2026
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Have an established diagnosis of axSpA by a rheumatologist (or other specialist with expertise in diagnosing axSpA).

• Study A (r-axSpA): Meet Assessment of SpondyloArthritis International Society (ASAS) classification criteria with radiographic sacroiliitis on X-ray as follows:

1. History of back pain >=12 weeks and age at onset of back pain <45 years, AND

2. Have radiographic bilateral grade 2-4 sacroiliitis or unilateral grade 3-4 sacroiliitis, based on New York grading system, confirmed by central reading, AND,

3. >=1 spondyloarthritis (SpA) feature.

• Study B (nr- axSpA): Meet ASAS classification criteria without radiographic sacroiliitis on X-ray as follows:

1. History of back pain >= 12 weeks and age at onset of back pain <45 years, AND

2. No radiographic bilateral grade 2-4 sacroiliitis or unilateral grade 3-4 sacroiliitis, AND,

3. Presence of sacroiliitis on MRI (based on central reading) and at least 1 SpA feature or when positive for human leukocyte antigen (HLA)-B27: having at least 2 SpA features, AND

4. Have objective signs of inflammation, by sacroiliitis on MRI or elevated CRP.

• Have active axSpA at screening and Day 1 defined by:

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 (numeric rating scale [NRS] 0-10), AND

• Spinal pain score >=4 (0-10 NRS) (based on BASDAI question 2),

• Have a history of inadequate response to >=2 NSAIDs at the maximum dose of NSAIDs used in axSpA for >=2 weeks each (a total duration of NSAID trial >=4 weeks) or intolerance to >=2 NSAIDs for the treatment of axSpA.

• Participants who are biologic disease-modifying antirheumatic drug (BDMARD)(s) experienced; defined as below.

• Participants designated as bDMARD(s)-inadequate responder(IR) must have received not more than 2 bDMARD(s), that was/were administered in accordance with its/their labeling and discontinued due to:

• Non-response (primary or secondary) after a minimum treatment of 12 weeks, and /or

• Intolerance (defined as having experienced an adverse reaction [e.g. an infusion/injection reaction, an infection, a laboratory test change, etc] irrespective of treatment duration)

• Participants designated as bDMARD(s) non-IR have previously received bDMARD(s) and have discontinued these due to other reasons than non-response or intolerance (e.g. economic reasons, treatment as part of a clinical study, other, or unknown).

• If continuing conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) during the study, participants are permitted to use only a maximum of 2 csDMARDs and must have been on this treatment for >=12 weeks prior to screening, with a stable dose and route of administration (defined as no change in prescription) for >4 weeks prior to Day 1.

• For participants aged 65 years or above on the date of signing the informed consent form (ICF), the investigator should carefully consider if participation is in the best interest of the participant.

Key Exclusion Criteria:

• Prior exposure to a Janus kinase inhibitor, investigational or approved, at any time, including filgotinib.

• Use of any opioid analgesic at average daily doses >30 mg/day of morphine (or equivalent) or use of unstable doses of any opioid analgesic <=2 weeks prior to Day 1.

• Use of any of the following systemic immunomodulating therapies <= 4 weeks prior to Day 1, including, but not limited to: 6-mercaptopurine, azathioprine, cyclosporine or other calcineurin inhibitors (e.g. sirolimus, tacrolimus), methotrexate if being discontinued, mycophenolate, antimalarials (e.g. hydroxychloroquine, chloroquine) if being discontinued, or sulfasalazine if being discontinued.

• Complete spinal ankylosis defined as the presence of consecutive bridging syndesmophytes in >=5 segments on the lateral radiograph (assessed by the central reader).

• Have undergone surgical treatments for peripheral manifestation of axSpA, including synovectomy or arthroplasty, or major surgery (requiring regional block or general anesthesia) <=12 weeks prior to Day 1 or planned major surgery during the study.

• Have a diagnosis of any generalized musculoskeletal disorder, e.g. generalized osteoarthritis, or systemic inflammatory condition other than axSpA.

• Have active Crohn's disease (CD) or active ulcerative colitis (UC). Note: participants may be enrolled if they have had a history of inflammatory bowel disease (IBD), including CD and UC, but have had no exacerbation within 6 months prior to Day 1, and, if currently on treatment, must be on stable treatment for >=6 months prior to Day 1 and this treatment should be allowed per protocol.

• Active autoimmune disease that would interfere with assessment of study parameters or increase risk to the participant by participating in the study (e.g. uncontrolled uveitis, uncontrolled thyroiditis, transverse myelitis, current peptic ulcer disease or prior history of severe diverticulitis [i.e. requiring hospitalization] or previous gastrointestinal perforation), per judgment of investigator,

• History of opportunistic infection, or immunodeficiency syndrome, which would put the participant at risk, as per investigator judgment,

• Active infection that is clinically significant, as per judgment of the investigator, or history of a serious infection (requiring hospitalization or systemic antibiotics) within 12 weeks prior to screening.

• Participant has a history of malignancy or myelo- or lymphoproliferative disorder, including non-melanoma skin cancer (NMSC), excised and curatively treated non-metastatic basal cell carcinoma, squamous cell carcinoma of the skin, or in situ uterine cervical carcinoma within the past 5 years prior to screening.

• Participant has any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. For participants at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past (>10 pack-years) and those at increased risk of cancer, the investigator should carefully consider if participation is in the best interest of the participant.

• Contraindication to magnetic resonance imaging (MRI).

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Drug:
• Filgotinib
Tablets administered orally once daily
• Placebo
Tablets administered orally once daily

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires de Bruxelles Hopital Erasme	Brussels
Belgium	ReumaClinic	Genk
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	UZ Leuven	Leuven
Belgium	CHU Helora	Mons
Bulgaria	Medical Center Rodopimed	Kardzhali
Bulgaria	MC Medconsult Pleven	Pleven
Bulgaria	Medical Center UNIMED EOOD	Plovdiv
Bulgaria	UMHAT Eurohospital Plovdiv	Plovdiv
Bulgaria	UMHAT Plovdiv AD	Plovdiv
Bulgaria	Medical Center Teodora	Ruse
Bulgaria	Medical Center 1 Sevlievo	Sevlievo
Bulgaria	DCC Ascendent EOOD	Sofia
Bulgaria	Dcc Focus 5 Meoh	Sofia
Bulgaria	Dcc Focus 5 Meoh Ood	Sofia
Bulgaria	DCC XVII-Sofia EOOD	Sofia
Bulgaria	Medical Center Hera	Sofia
Bulgaria	Medical Center N I PIROGOV	Sofia
Bulgaria	Military Medical Academy MHAT	Sofia
Bulgaria	UMHAT Sofiamed OOD	Sofia
Bulgaria	UMHAT Stoyan Kirkovich AD	Stara Zagora
Croatia	CHC Rijeka Immunology Department	Rijeka
Croatia	Poliklinika Bonifarm	Zagreb
Croatia	Poliklinika K-Centar	Zagreb
Czechia	Fakultni nemocnice u sv Anny, Interni klinika	Brno
Czechia	Lekarna BENU	Brno
Czechia	Revmaclinic s r o	Brno
Czechia	Revmatologie s r o	Brno
Czechia	Artroscan s r o	Ostrava
Czechia	CCR Ostrava	Ostrava
Czechia	Vesalion Revma ambulance	Ostrava
Czechia	ARTHROHELP s r o	Pardubice
Czechia	CCR Czech a s	Pardubice
Czechia	Fakultni nemocnice Motol	Prague
Czechia	Lekarna U Revmatologickeho	Prague	Nove Mesto
Czechia	MUDR. Zuzana URBANOVA Revmatologie	Prague
Czechia	Medical Plus Sro	Uherske Hradiste
Czechia	PV Medical Services	Zlín
Estonia	Clinical Research Centre	Tartu
Estonia	Meditrials OU	Tartu
France	APHP Hopital Ambroise Pare	Boulogne Billancourt
France	Hopital Edouard Herriot	Lyon
France	CHR d'Orleans	Orleans Cedex 2
France	Centre Hospitalier Lyon Sud	Pierre Benite Cedex
France	Hopital Charles Nicolle	Rouen
Germany	Charite Medizinische Klinik I	Berlin
Germany	Hamburger Rheuma II	Hamburg
Germany	Rheumazentrum Ruhrgebiet	Herne
Germany	Klinische Forschung im med	Planegg
Germany	Universitatsklinikum Wurzburg	Wurzburg
Greece	General Hospital of Athens Laiko	Athens
Greece	University General Hospital "Attikon"	Athens
Hungary	Revita Rheumatologiai Kft	Budapest
Hungary	University of Debrecen	Debrecen
Hungary	Reumatologiai es Immunologiai	Pecs
Hungary	Vita Verum Medical	Szekesfehervar
Hungary	Obudai Egeszsegugyi Centrum	Zalaegerszeg
Italy	Istituto Ortopedico Rizzoli	Bologna
Italy	Azienda Ospedaliera Universitaria Luigi Vanvitelli	Napoli
Italy	Policlinico Paolo Giaccone	Palermo
Italy	Policlinico Uni Campus Bio-Med	Rome
Italy	Policlinico Universitario Agostino Gemelli	Rome
Italy	Ospedale SM Misericordia	Udine
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Lithuania	Kaunas City Polyclinic	Kaunas
Lithuania	Kaunas Hospital of LUHSCP	Kaunas
Lithuania	Klaipeda University Hospital, Public Institution	Klaipeda
Lithuania	Vilnius UH Santariskiu Clinics	Vilnius
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	UMCG	Groningen
Netherlands	Zuyderland Medisch Centrum	Heerlen
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Philippines	Lipa Medix Medical Center	Lipa City
Philippines	Mary Mediatrix Medical Center	Lipa City
Philippines	Ospital Ng Makati	Makati City	Metro Manila
Philippines	Medical Center Manila	Manila
Philippines	The Medical City Clark, Mabalacat	Pampanga
Philippines	Far Eastern University - Dr. Nicanor Reyes Medical Foundation	Quezon City
Philippines	St. Luke's Medical Center	Quezon City
Philippines	Ilocos Training and Regional Medical Center	San Fernando	La Union
Poland	ZDROWIE Osteo Medic	Bialystok
Poland	Centrum Kliniczno Badawcze	Elblag
Poland	Silmedic sp. z o. o	Katowice
Poland	Reumed Spolka z o o	Lubin
Poland	KO-MED Centra Kliniczne	Lublin
Poland	Twoja Przychodnia NCM	Nowa Sol
Poland	ETYKA Osrodek Badan Klinicznyc	Olsztyn
Poland	TPO Centrum Medyczne	Opole
Poland	AI Centrum Medyczne	Poznan
Poland	Solumed Medical Center	Poznan
Poland	Twoja Przychodnia PCM	Poznan
Poland	KO-MED Centra Kliniczne	Staszów
Poland	MICS Medical Center Torun	Torun
Poland	Instytut Reumatologii im. Eleonory Reicher	Warsawa
Poland	Klinika Reuma Park	Warsawa
Poland	ETG Warszawa	Warszawa
Poland	MICS Centrum Medyczne	Warszawa
Poland	FutureMeds Wroclaw	Wroclaw
Romania	Sj de Urgenta Bacau	Bacau
Romania	S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L	Brasov
Romania	SC Delta Health Care SRL	Bucharest
Romania	Spitalul Clinic Judetean de Urgenta	Cluj-Napoca
Romania	Aqua Med Consulting SRL	Constanta
Romania	SC Medisof Diagnostic SRL	Craiova
Romania	Centrul Medical Unirea SRL	Iasi
Romania	Sc Medaudio Optica Srl	Ramnicu Valcea
Romania	S.C Centrul Medical Unirea SR	Târgu-Mures
South Africa	Clinresco Centres Pty Ltd,	Kempton Park
South Africa	Arthritis Clinical Trial Centre	Pinelands
South Africa	Emmed Research	Pretoria
South Africa	Winelands Medical Research Centre	Stellenbosch
Spain	Hospital Marina Baixa	Alicante
Spain	UH Parc Tauli	Barcelona
Spain	Hospital Universitario Basurto	Bilbao
Spain	HU Reina Sofia	Córdoba
Spain	Hospital Universitario La Paz	Madrid
Spain	HU Marques de Valdecilla	Santander
Spain	Clinica GAIAS Santiago	Santiago De Compostela
Spain	HU Virgen Macarena	Sevilla
Spain	UH Virgen de Valme	Sevilla
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Taipei Medical University Hospital	Taipei city
United Kingdom	Royal United Hospital Bath NHS Foundation Trust	Bath
United Kingdom	Norfolk & Norwich University Hospital	Norwich

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Croatia,  Czechia,  Estonia,  France,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Lithuania,  Netherlands,  Philippines,  Poland,  Romania,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving SpondyloArthritis International Society 40% improvement (ASAS40) Response (Yes/No) at Week 16		Week 16
Secondary	Change from baseline in Ankylosing Spondylitis DiseaseActivity Score with C-reactive protein (ASDASCRP) at Week 16		Week 16
Secondary	Change from baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score of Sacroiliac Joints (SIJs) at Week 16		Week 16
Secondary	Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16		Week 16
Secondary	Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16		Week 16
Secondary	Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) (linear score) at Week 16		Week 16
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs), TE Serious Adverse Events, and TEAEs Leading to Treatment Discontinuation at Week 16		Week 16