Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Fulranumab is an investigational small molecule being developed for the treatment of osteoarthritis, specifically for pain associated with osteoarthritis of the hip or knee. It has been studied in Phase 3 clinical trials, but it is not approved and remains in clinical development.
Fulranumab is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational small molecule intended for the treatment of osteoarthritis pain.
Fulranumab has completed Phase 3 clinical trials for osteoarthritis. It is an investigational drug and is not approved by regulatory authorities. All four clinical trials for Fulranumab have been completed, with no active trials currently ongoing.
Fulranumab has been studied in four completed Phase 3 trials: NCT02289716 (monotherapy, 41 patients), NCT02301234 (adjunctive use, 111 patients), NCT02336685 (adjunctive use, 79 patients), and NCT02336698 (monotherapy, 18 patients). All trials involved patients with osteoarthritis of the hip or knee.
Fulranumab is a small molecule, but its specific molecular target is not disclosed in the available information. It has been evaluated in randomized, double-blind, placebo-controlled trials for the treatment of pain associated with osteoarthritis of the hip or knee.