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Clinical Trials in Germany / NCT05785611
Active, not recruiting Phase 3

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

NCT05785611 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2023-04-05
Last updated
2025-12-04

Condition(s) studied

Axial Spondyloarthritis

Investigational drug(s) / intervention(s)

Filgotinib →Placebo

Filgotinib: Tablets administered orally once daily

Placebo: Tablets administered orally once daily

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (123)

FacilityCityRegionStatus
Cliniques Universitaires de Bruxelles Hopital Erasme Brussels Belgium
ReumaClinic Genk Belgium
Universitair Ziekenhuis Gent Ghent Belgium
UZ Leuven Leuven Belgium
CHU Helora Mons Belgium
Medical Center Rodopimed Kardzhali Bulgaria
MC Medconsult Pleven Pleven Bulgaria
UMHAT Plovdiv AD Plovdiv Bulgaria
UMHAT Eurohospital Plovdiv Plovdiv Bulgaria
Medical Center UNIMED EOOD Plovdiv Bulgaria
Medical Center Teodora Rousse Bulgaria
Medical Center 1 Sevlievo Sevlievo Bulgaria
DCC Ascendent EOOD Sofia Bulgaria
UMHAT Sofiamed OOD Sofia Bulgaria
Dcc Focus 5 Meoh Ood Sofia Bulgaria
Dcc Focus 5 Meoh 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 Stoyan Kirkovich AD Stara Zagora Bulgaria
Lekarna U Revmatologickeho Prague Nove Mesto
Fakultni nemocnice u sv Anny, Interni klinika Brno Czechia
Revmaclinic s r o Brno Czechia
Lekarna BENU Brno Czechia
Revmatologie s r o Brno Czechia
CCR Ostrava Ostrava Czechia
Vesalion Revma ambulance Ostrava Czechia
Artroscan s r o Ostrava Czechia
ARTHROHELP s r o Pardubice Czechia
CCR Czech a s Pardubice Czechia
MUDR. Zuzana URBANOVA Revmatologie Prague Czechia
Fakultni nemocnice Motol Prague Czechia
Medical Plus Sro Uherské Hradiště Czechia
PV Medical Services Zlín Czechia
Clinical Research Centre Tartu Estonia
Meditrials OU Tartu Estonia
APHP Hopital Ambroise Pare Boulogne-Billancourt France
Hopital Edouard Herriot Lyon France
CHR d'Orleans Orléans France

+ 83 more sites — see the full list on the official registry below.

More Alfasigma S.p.A. trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05785611 on ClinicalTrials.gov ↗ ← All trials in Germany