Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3002

NCT ID: NCT02336698

Last Updated: 2017-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-13
• Study Completion Date: 2016-09-15

Brief Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.

Detailed Description

This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled (an inactive substance is given to one group of participants while active drug is given to another group of participants to see if there is a difference in response), parallel-group (study drugs given to participants in all treatment groups during the same time period) to evaluate the efficacy (capacity of the investigational drug to produce an effect), safety, and tolerability of fulranumab administered as monotherapy (alone; not in combination with other drug therapy) to participants with chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis (OA) that is not adequately controlled by current pain therapy. The duration of participation in the study for an individual participant will be up to 67 weeks (includes a screening period of 3 weeks, a double-blind treatment period of 16 weeks, and a post-treatment follow-up period of up to 48 weeks).). All participants will be randomly assigned in a 1:1:1 ratio to 1 of 3 treatments (placebo, fulranumab 1mg, fulranumab 3mg) and given a single injection subcutaneously (under the skin) once every 4 weeks for up to 16 weeks. Blood samples will be collected from each participant at time points during the study. Safety evaluations will include assessment of adverse events, physical examinations, laboratory tests and vital signs which will be monitored throughout the study.

Conditions

Osteoarthritis; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.

Fulranumab 1 mg

Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks).

Group Type: EXPERIMENTAL

Fulranumab 1 mg

Intervention Type: DRUG

Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.

Fulranumab 3 mg

Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks).

Group Type: EXPERIMENTAL

Fulranumab 3 mg

Intervention Type: DRUG

Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.

Interventions

Placebo

Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.

Intervention Type: DRUG

Fulranumab 1 mg

Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.

Intervention Type: DRUG

Fulranumab 3 mg

Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.

Intervention Type: DRUG

Eligibility 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); For participants in the USA and Canada: Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids other than codeine or codeine combination products)
• 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

Exclusion Criteria

• Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)
• Unstable or progressive neurologic disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Phoenix, Arizona, United States

Costa Mesa, California, United States

Laguna Hills, California, United States

Lakewood, California, United States

Northridge, California, United States

Santa Clarita, California, United States

Thousand Oaks, California, United States

Boynton Beach, Florida, United States

Lake Clarke Shores, Florida, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Wichita, Kansas, United States

Bay City, Michigan, United States

Caro, Michigan, United States

Grand Rapids, Michigan, United States

Somerset, New Jersey, United States

Greenville, North Carolina, United States

Charleston, South Carolina, United States

Memphis, Tennessee, United States

Bedford, Texas, United States

Cypress, Texas, United States

Houston, Texas, United States

Waxahachie, Texas, United States

Riverton, Utah, United States

Norfolk, Virginia, United States

Elblag, , Poland

A Coruña, , Spain

Barcelona, , Spain

Mérida, , Spain

Santiago de Compostela, , Spain

Stourton, , United Kingdom

Countries

United States; Poland; Spain; United Kingdom

References

Kelly KM, Sanga P, Zaki N, Wang S, Haeussler J, Louie J, Thipphawong J. Safety and efficacy of fulranumab in osteoarthritis of the hip and knee: results from four early terminated phase III randomized studies. Curr Med Res Opin. 2019 Dec;35(12):2117-2127. doi: 10.1080/03007995.2019.1653068. Epub 2019 Sep 13.

Reference Type: DERIVED

PMID: 31387410 (View on PubMed)

Other Identifiers

42160443PAI3002

Identifier Type: OTHER

Identifier Source: secondary_id

2014-003879-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100069

Identifier Type: -

Identifier Source: org_study_id