Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3003

Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fulranumab as Monotherapy in Subjects with Signs and Symptoms of Osteoarthritis of the Hip or Knee

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002598-13-BE

Enrollment

450

Registered

2015-03-12

Start date

2015-09-15

Completion date

Unknown

Last updated

2017-01-23

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

Conditions

Osteoarthritis of the Hip or Knee MedDRA version: 18.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859 MedDRA version: 18.1 Level: LLT Classification code 10020108 Term: Hips osteoarthritis System Organ Class: 100000004859

Interventions

Product Name: Fulranumab Product Code: JNJ-42160443 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Fulranumab CAS Number: 902141-80-4 Current Sponsor code: JNJ-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Clinical diagnosis of osteoarthritis (OA) of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class =2) of the study joint; - Scheduled joint replacement or planning to undergo a joint replacement surgery for the study joint; - Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAID, and an opioid; - Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA; - During treatment and within 24 weeks after the last injection of study drug: if female of childbearing potential, is not pregnant, breast-feeding, or planning to become pregnant, or if male, will not father a child. 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 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: -Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA) -Unstable or progressive neurologic disorders

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to demonstrate the efficacy using 2 co-primary endpoints (as measured by the changes from baseline to the end of Week 16 in the Western Ontario and McMaster University Osteoarthritis Index [WOMAC] pain and physical function subscales, and Patient Global Assessment [PGA] scores), safety, and tolerability of fulranumab subcutaneous (SC) injections as monotherapy compared with placebo in subjects with signs and symptoms of osteoarthritis of the hip or knee. ;Secondary Objective: To evaluate the effect of fulranumab on: - Patient Global Assessment (PGA) - Joint pain using Numerical Rating Scale (NRS) - Stiffness, sleep, functional status and well-being as perceived by the subject - Supplemental analgesic pharmacologic therapy use - Pharmacokinetics and immunogenicity of fulranumab;Primary end point(s): - Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score - Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) physical function subscale score;Timepoint(s) of evaluation of this end point: Baseline, Week 16	—

Measure

Time frame

Main Objective: The primary objective is to demonstrate the efficacy using 2 co-primary endpoints (as measured by the changes from baseline to the end of Week 16 in the Western Ontario and McMaster University Osteoarthritis Index [WOMAC] pain and physical function subscales, and Patient Global Assessment [PGA] scores), safety, and tolerability of fulranumab subcutaneous (SC) injections as monotherapy compared with placebo in subjects with signs and symptoms of osteoarthritis of the hip or knee. ;Secondary Objective: To evaluate the effect of fulranumab on: - Patient Global Assessment (PGA) - Joint pain using Numerical Rating Scale (NRS) - Stiffness, sleep, functional status and well-being as perceived by the subject - Supplemental analgesic pharmacologic therapy use - Pharmacokinetics and immunogenicity of fulranumab;Primary end point(s): - Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score - Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) physical function subscale score;Timepoint(s) of evaluation of this end point: Baseline, Week 16

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Timepoints listed above in endpoints.;Secondary end point(s): Change from baseline to the end of the 16-week double-blind phase in scores in: - WOMAC Stiffness subscale - Daily NRS scores - MOS Sleep subscales - SF-36 subscales - EQ-5D-5L - Patient Global Assessment (PGA) score	—

Countries

Austria, Belgium, Canada, Czech Republic, France, Netherlands, Poland, Romania, Slovakia, Spain, United Kingdom, United States

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International NV

ClinicalTrialsEU@its.jnj.com+3171524 2166

Outcome results

None listed

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