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Fulranumab · 4 trials · 2 indications
The WOMAC 3.1 is a multi-dimensional, osteoarthritis (OA) specific self-administered questionnaire using 24 questions with a 48-hour recall that are grouped into 3 subscales (pain, stiffness, and physical function) associated with hip or knee OA. Pain, stiffness, and physical function is rated on a scale of 0-10 (0 = less severe up to 10 = more severe).
See WOMAC 3.1 described above.
The PGA is part of a comprehensive assessment of the impact of treatment for osteoarthritis that also includes pain and physical function. The PGA included in the present study indicates the perception of osteoarthritis in the study joint at the current time. Ratings are provided on an 11-point numerical rating scale from 0 ("Very Good") to 10 ("Very Bad").
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks). |
| Fulranumab 1 mg | EXPERIMENTAL | Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks). |
| Fulranumab 3 mg | EXPERIMENTAL | Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks). |
| Name | Type | Description |
|---|---|---|
| Placebo | 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 | 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 | DRUG | Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen. |
| Opioid | DRUG | Opioids will be administered as standard of care for osteoarthritis (OA) pain therapy during the double-blind treatment phase as per investigator discretion. |
| Celecoxib 100 mg | DRUG | Double-blind capsules taken twice daily for up to 16 weeks. |
| Celecoxib 100 mg Matching Placebo | DRUG | Double-blind capsules taken twice daily for up to 16 weeks. |
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 s...
Top 5 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
Fulranumab was developed for the treatment of osteoarthritis, specifically osteoarthritis of the hip or knee, with associated pain. It is a monoclonal antibody studied as an investigational therapy in adults 18 years and older. All four of its Phase 3 trials enrolled participants with osteoarthritis and pain.
Fulranumab targets nerve growth factor, or NGF. It is a monoclonal antibody that acts as an inhibitor of NGF. By binding NGF, the antibody is designed to interfere with NGF signaling, which is associated with pain transmission in conditions such as osteoarthritis.
Fulranumab was developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical program evaluating the monoclonal antibody in osteoarthritis of the hip or knee.
Fulranumab reached Phase 3 clinical development for osteoarthritis. It is an investigational monoclonal antibody and is not approved. All four of its Phase 3 trials are completed, and no trials are currently active.
Fulranumab was studied in four completed Phase 3 trials: NCT02336698, NCT02336685, NCT02301234, and NCT02289716. These randomized, double-blind, placebo-controlled studies evaluated fulranumab as monotherapy or adjunctive therapy in osteoarthritis of the hip or knee, with total enrollment of 249 participants across multiple countries.