A study to look at fluid from knee and hip joints in studies with fasinumab for treatment of adults with pain from osteoarthritis of the knee or hip

Study to Evaluate Synovial Fluid in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001411-71-GB

Enrollment

131

Registered

2018-09-26

Start date

2018-12-03

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain due to osteoarthritis of the knee MedDRA version: 20.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859

Interventions

Product Name: Fasinumab Product Code: REGN475 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Fasinumab CAS Number: 1190239-42-9 Current Sponsor code: REGN475 Ot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Eligible for and have signed the informed consent form (ICF) for R475-PN-1523, R475-OA-1611, or R475-OA-1688 2. Index joint is the knee 3. Baseline K-L score of 2 or 3 in index knee joint 4. Effusion of index knee joint at baseline, evident on screening MRI from parent study 5. Willing to undergo 2 ultrasound guided joint aspirations of index knee joint 6. Willing and able to comply with clinic visits and study-related procedures 7. Provide informed consent signed by study patient or legally acceptable representative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: 1. Screen failed for the parent study prior to randomiSation visit, after having signed the ICFs for both the parent study and study R475-OA-1815 2. Effusion no longer present at time of ultrasound guided aspiration

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Not applicable;Primary end point(s): The endpoints of this exploratory study are: • Change and percent change from baseline to week 16 in synovial fluid biomarkers reflecting bone turnover (procollagen type 1 N-terminal peptide [P1NP] and type-I collagen degraded by matrix metalloproteinase [C1M]), cartilage turnover (type-II collagen degraded by matrix metalloproteinase [C2M]) and inflammation (type-III collagen degraded by matrix metalloproteinase [C3M]) • Change and percent change from baseline to week 16 in synovial fluid white blood cell (WBC) count • Change and percent change from baseline to week 16 in crystal count/high powered field • Number and percentage of patients at baseline and week 16 with semi-quantitative measure of crystals (ie, no crystals, few crystals, moderate amount of crystals, many crystals) • Change and percent change from baseline to week 16 in intracellular crystal count/high powered field;Timepoint(s) of evaluation of this end point: Baseline and week 16;Main Objective: The objective of this exploratory study is to evaluate changes in synovial fluid biomarkers in patients with OA who have been treated with fasinumab compared to those treated with placebo or NSAIDs.	—

Measure

Time frame

Secondary Objective: Not applicable;Primary end point(s): The endpoints of this exploratory study are: • Change and percent change from baseline to week 16 in synovial fluid biomarkers reflecting bone turnover (procollagen type 1 N-terminal peptide [P1NP] and type-I collagen degraded by matrix metalloproteinase [C1M]), cartilage turnover (type-II collagen degraded by matrix metalloproteinase [C2M]) and inflammation (type-III collagen degraded by matrix metalloproteinase [C3M]) • Change and percent change from baseline to week 16 in synovial fluid white blood cell (WBC) count • Change and percent change from baseline to week 16 in crystal count/high powered field • Number and percentage of patients at baseline and week 16 with semi-quantitative measure of crystals (ie, no crystals, few crystals, moderate amount of crystals, many crystals) • Change and percent change from baseline to week 16 in intracellular crystal count/high powered field;Timepoint(s) of evaluation of this end point: Baseline and week 16;Main Objective: The objective of this exploratory study is to evaluate changes in synovial fluid biomarkers in patients with OA who have been treated with fasinumab compared to those treated with placebo or NSAIDs.

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Poland, United Kingdom, United States

Contacts

Public ContactClinical Trial Information

Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026