Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GLPG0259 solution, GLPG0259 fumarate, GLPG0259 free base, GLPG0259 oral capsule
GLPG0259 · 5 trials · 2 indications
The primary efficacy endpoint will be the number and percentage of subjects in each GLPG0259 dose group and placebo group achieving an American College of Rheumatology (ACR)20 (ACR20 response rate) at Week 12.
| Arm | Type | Description |
|---|---|---|
| GLPG0259 (Part A) | EXPERIMENTAL | - |
| Placebo (Part A) | PLACEBO_COMPARATOR | - |
| GLPG0259 (Part B) | EXPERIMENTAL | - |
| Placebo (Part B) | PLACEBO_COMPARATOR | - |
| Single oral dose, single capsule | EXPERIMENTAL | - |
| Single oral dose, two capsules | EXPERIMENTAL | - |
| Single oral dose, solution | EXPERIMENTAL | - |
| Single oral dose, solid, fasted | EXPERIMENTAL | - |
| Single oral dose, solid, fed. | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | GLPG0259 25/50/75 mg/day for 14 days |
| 2 | PLACEBO_COMPARATOR | placebo for 14 days |
| 3 | EXPERIMENTAL | multiple dose, 5 days, oral solution |
| 4 | PLACEBO_COMPARATOR | multiple dose, 5 days, oral solution |
| Name | Type | Description |
|---|---|---|
| GLPG0259 oral capsule | DRUG | Two capsules, each containing 25 mg of GLPG0259 (i.e. 50 mg/day), to be given once daily; in case of adverse events the dose may be split over two administrations, or reduced to 25 mg/day (one single capsule) |
| Placebo | DRUG | Placebo capsules; two capsules to be taken in the morning, in case of adverse events the dose may be split over two administrations, or reduced to one single capsule |
| GLPG0259 (Part B) | DRUG | Capsule, dosage to be established based on results of Part A |
| Placebo (Part B) | DRUG | Capsules, dosage to be established after Part A, and matching GLPG0259 (Part B) |
| GLPG0259 fumarate | DRUG | single oral dose, two capsules each containing 25 mg of GLPG0259 fumarate |
| GLPG0259 free base | DRUG | single oral dose, GLPG0259, 50 mg solid formulation |
| GLPG0259 solution | DRUG | single oral dose, GLPG0259, 50 mg oral solution |
| GLPG0259 | DRUG | single oral dose, GLPG0259, 50 mg solid formulation |
| Methotrexate | DRUG | 7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14 |
Inclusion Criteria: * Must have active RA (≥5 tender or painful joints on motion and ≥5 joints swollen AND a C-reactive protein (CRP) concentration ≥1.5 mg/dL). * Must have been on methotrexate for ≥6 months at a stable dose of 7.5-25 mg/week for ≥12 weeks, to be continued throughout study; * If on...
Top 20 of 27 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Adalimumab, Upadacitinib, Lutikizumab, Ravagalimab |
| Bristol-Myers Squibb Company | BMY | 6 | PHASE3 | Abatacept, Zolacabtagene autoleucel, BMS-986528, BMS-986454 |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Baricitinib, LY4213663, LY4298445 |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Guselkumab |
| AstraZeneca PLC | AZN | 4 | PHASE2 | AZD1163, AZD0120, AZD5492, Surovatamig |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE2 | Ianalumab, PIT565, Secukinumab |
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Tulisokibart, MK-1045 |
| AnaptysBio, Inc. | ANAB | 1 | PHASE2 | Rosnilimab |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | Sarilumab, SAR448501 |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| XBiotech, Inc. | XBIT | 1 | PHASE2 | Natrunix |
| Amgen Inc. | AMGN | 1 | PHASE2 | Inebilizumab, Blinatumomab |
| Artiva Biotherapeutics, Inc. | ARTV | 2 | PHASE2 | AB-101 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE1 | GS-0151 |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
| Xencor, Inc. | XNCR | 1 | PHASE1 | Plamotamab |
| Adicet Bio Inc | ACET | 1 | PHASE1 | ADI-001 |
| Pfizer Inc. | PFE | 2 | - | tofacitinib |
| Jade Biosciences, Inc. | JBIO | 1 | PHASE1 | JADE201 |