Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK3196165 · 1 trial · 1 indication
Participants were required to complete a daily pain NRS based on their 24-hour average hand pain intensity with the anchors "0" (no pain) and "10" (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The 7 day average score was calculated as sum of daily 24 hours average hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visit value minus Baseline value. Intent-To-Treat Population comprised of all randomized participants who received at least one dose of study treatment (GSK3196165 or placebo).
| Arm | Type | Description |
|---|---|---|
| GSK3196165 | EXPERIMENTAL | Subjects will receive a total of 8 doses of GSK3196165 over a 12-week treatment period. |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive a total of 8 doses of placebo over a 12-week treatment period. |
| Name | Type | Description |
|---|---|---|
| GSK3196165 | DRUG | GSK3196165 will be supplied as a liquid and will be administered as a subcutaneous injection. The drug will be administered weekly for 5 injections, then every other week for 3 further injections. |
| Placebo | DRUG | Matching placebo will be administered as above. |
Inclusion Criteria: * Age \>=18 years at the time of signing informed consent. * Meets American College of Rheumatology (ACR) classification of osteoarthritis (OA) and have not responded to analgesics (level 1 and 2) or to non-steroidal anti-inflammatory drugs (NSAIDs) for at least 10 days in the p...
GSK3196165 is an investigational small molecule being studied for rheumatoid arthritis and osteoarthritis. In clinical trials, it has been evaluated in combination with methotrexate for active moderate-to-severe rheumatoid arthritis and for inflammatory hand osteoarthritis. It is not approved and remains in clinical development.
GSK3196165 is being developed by GSK plc, a global biopharmaceutical company listed on the New York Stock Exchange under the ticker GSK. The company has sponsored multiple clinical trials of the drug across North America, Europe, and Asia.
GSK3196165 is in Phase 2 clinical development. It has completed Phase 2 trials for rheumatoid arthritis and osteoarthritis, as well as a Phase 1 pharmacokinetic study in Japanese patients with rheumatoid arthritis. The drug is investigational and not approved for any use.
GSK3196165 has been studied in several completed trials. NCT02504671 evaluated it with methotrexate in moderate-severe rheumatoid arthritis. NCT02683785 investigated it in inflammatory hand osteoarthritis. NCT02799472 was a mechanistic study in rheumatoid arthritis, and NCT03028467 assessed pharmacokinetics in Japanese patients.
GSK3196165 is the code name used in clinical trials for this investigational compound. No alternative brand name or other designation has been reported for it. The drug is identified solely by this code in the studies conducted to date.