A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis (Roccella)

Galapagos

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: Placebo; Drug: GLPG1972

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03595618

2017-004581-10 (EudraCT Number)

GLPG1972-CL-201

U1111-1205-0321 (Other Identifier)

Details and patient eligibility

About

This study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.

Enrollment: 932 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male participants or female participants of non-childbearing potential and not breastfeeding.
• Body weight > 40 kg, body mass index (BMI) < 40 kg/m^2.
• Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology.
• History of knee pain for at least 6 months and on the majority of days (> 50%) during the preceding month.
• Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (VAS, 100 mm) at screening and inclusion visits.
• Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics

Exclusion criteria

• Severe clinical knee malalignment according to the investigator.
• Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral side).
• Knee prosthesis already foreseen within the study period (whichever side).
• Hip prosthesis recently implanted (< 1 year) or foreseen within the study period (whichever side).
• Previous osteotomy on the inferior limbs (whichever side).
• Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study.
• Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study.
• Other pathologies affecting the target knee.
• Any contraindication to magnetic resonance imaging (MRI) including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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932 participants in 4 patient groups, including a placebo group

GLPG1972 75 mg

Experimental group

Description:

Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.

Treatment:

Drug: GLPG1972

Drug: Placebo

GLPG1972 150 mg

Experimental group

Description:

Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.

Treatment:

Drug: GLPG1972

Drug: Placebo

GLPG1972 300 mg

Experimental group

Description:

Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.

Treatment:

Drug: GLPG1972

Placebo

Placebo Comparator group

Description:

Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.

Treatment:

Drug: Placebo