A study to determine the long-term safety and the efficacy of fasinumab for treatment of adults with pain from osteoarthritis of the knee or hip

• Register: EUCTR
• Last refreshed on: 29 November 2021
• Main ID: EUCTR2015-003783-36-PL
• Date of registration: 19/04/2016
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals, Inc.
• Public title: A study to determine the long-term safety and the efficacy of fasinumab for treatment of adults with pain from osteoarthritis of the knee or hip
• Scientific title: A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients with Pain Due to Osteoarthritis of the Knee or Hip
• Date of first enrolment: 22/04/2016
• Target sample size: 7000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003783-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Estonia, France, Germany, Hong Kong, Hungary, Italy, Lithuania, Mexico, Peru, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trial Information
• Affiliation: Regeneron Pharmaceuticals, Inc.

• Name: Clinical Trial Information
• Affiliation: Regeneron Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
1) Male or female > 18 years of age at the screening visit
2) Clinical diagnosis of OA of knee or hip based on ACR criteria with radiologic evidence of OA and moderate to severe pain in an eligible joint defined by WOMAC pain subscore
3) Willing to discontinue current pain medication
4) A history of 12 weeks of analgesic use for OA of the knee or hip as defined by:
- Inadequate pain relief from paracetamol/acetaminophen, and
- Intolerance or inadequate pain relief from at least 1 oral NSAID, and
- Intolerance to or inadequate pain relief from opioid therapy, unwillingness to take opioid therapy for a medically acceptable reason, or lack of access to opioid therapy
5) History of regular use of analgesic medications for OA pain
Additional Inclusion Criteria for Sub-study Patients
1) Willing to discontinue glucosamine sulphate and chondroitin sulphate treatments during the initial 16 weeks of treatment.
2) Stable treatment with glucosamine sulphate and chondroitine sulphate treatments must be stopped during the pre-randomization period.
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 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5000

Exclusion criteria:
1) Joint diseases or other underlying conditions that can confound with the study parameters
2) Recent use of systemic or intra-articular corticosteroids
3) Evidence of destructive arthropathy
4) Evidence of autonomic or other neuropathy
5) Scheduled for joint replacement surgery during the trial
6) Other medical conditions that may interfere with participation or accurate assessments during the trial
7) Member of the clinical site study team and/or his/her immediate family
8) Pregnant or breastfeeding women


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pain due to osteoarthritis of the knee or hip
MedDRA version: 21.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
MedDRA version: 21.1 Level: LLT Classification code 10020108 Term: Hips osteoarthritis System Organ Class: 100000004859

Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Intervention(s)

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
Other descriptive name: FASINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2 -
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

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
Other descriptive name: FASINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2 -
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip.

Primary end point(s): The primary endpoint in the study is safety monitoring including AE incidence, SAE incidence, AESI incidence, changes in safety laboratory analyses, and incidence of anti fasinumab antibody formation from baseline to week 52 (treatment period 1 and 2) and to week 72 (end of follow-up period).

Secondary Objective: •To assess the use of paracetamol/acetaminophen for the fasinumab
arms compared to placebo from baseline to week 16
•To assess the use of paracetamol/acetaminophen for the fasinumab
arms compared to placebo from baseline to week 52
•To assess the use of standard of care analgesic medication, including
NSAIDs, for non OA pain in patients randomized to fasinumab compared
to placebo from week 16 through the end of treatment
•To assess time to JR

Timepoint(s) of evaluation of this end point: At week 52 and week 72

Secondary Outcome(s)

Secondary end point(s): Other exploratory endpoints in the study are:
•The proportion of patients taking rescue medication, number of days on rescue medication, and weekly average usage of rescue medication
•The percent of patients using standard-of-care analgesic medication
•Time to JR decision
•Survey of Autonomic Symptom scores

Timepoint(s) of evaluation of this end point: At week 52 and week 72

Secondary ID(s)

2015-003783-36-BG

R475-PN-1523

Source(s) of Monetary Support

Regeneron Pharmaceuticals, Inc.

Ethics review

Status: Approved
Approval date: 04/04/2016
Contact: