A study evaluating the effect of Filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriaticarthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.

Phase 2

• Conditions: Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

• Registration Number: CTRI/2019/09/021290
• Lead Sponsor: Galapagos NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Key inclusion criteria:

1) Males between the ages of 21 and 65 (inclusive) on the day of signing informed consent

2) Diagnosis of RA, PsA, AS, or nrAxSpA for at least 12 weeks prior to Screening, meeting the corresponding specific classification criteria:

RA, American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) 2010,

PsA, Classification criteria for Psoriatic Arthritis (CASPAR) criteria, AS or nrAxSpA, Assessment of Spondyloarthritis International Society (ASAS) criteria for axial spondyloarthritis,

3) For RA, PsA, AS, or nrAxSpA, subject meets the following criteria:

For RA,

Inadequate response or intolerant to >=12-weeksâ?? course of csDMARD or biological DMARD (bDMARD) therapy for RA, Have an Clinical Disease Activity Index (CDAI) >10 at Screening

For PsA,

Inadequate response or intolerant to >=12-weeksâ?? course of csDMARD or bDMARD therapy for PsA,

Have a Disease Activity in Psoriatric Arthritis (DAPSA) score >14 at Screening,

For Axial Spondyloarthritis (applicable to those with diagnosis of AS or nrAxSpA),

Inadequate response or intolerant to at least 2 NSAIDs which may include COX-2 inhibitors prescribed for a total period of >=4 weeks OR to an >=12 week course of csDMARD or biological disease modifying anti-rheumatic drug (bDMARD) therapy for spondyloarthritis,

Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 at Screening,

At Screening, subjects should have a high-sensitivity C-reactive protein (hsCRP) >0.3 mg/dL OR sacroiliitis according to the modified New York (NY) criteria OR a history of active inflammation on magnetic resonance imaging (MRI) consistent with sacroiliitis within 2 years of screening.

4) The mean of 2 separate semen samples collected at Screening must meet the following minimum criteria (in accordance with Section 6.11 of Protocol) semen volume >=1.5 mL, total sperm/ejaculate >=39 million, sperm concentration >=15 million/mL, sperm total motility >=40%, and normal sperm morphology >=30%

Complete list of study inclusion please refer to Sections 4.2 of Protocol

Exclusion Criteria

Key Exclusion Criteria:

1) Previously or currently documented problems with male reproductive health including but not limited to primary hypogonadism, secondary hypogonadism, or reduced fertility

2) Use of any prohibited concomitant medication(s) as described in Section 5.3 (and Table 5-1) of Protocol

3) Active tuberculosis or untreated latent tuberculosis (Section 4.2 Inclusion Criteria, 10)

4) Infection with Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) (Section 4.3, Exclusion Criteria, #22-24) of Protocol

Complete list of study exclusion please refer to Sections 4.3 of Protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified