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LX3305 · 3 trials · 1 indication
Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 20% response criteria (ACR20) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR20, there had to be ≥20% improvement in swollen joint count, ≥20% improvement in painful/tender joint count, and ≥20% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).
7-OH-MTX is the primary metabolite of methotrexate.
| Arm | Type | Description |
|---|---|---|
| Low Dose | EXPERIMENTAL | A low dose of LX3305; daily oral intake for 12 weeks |
| Mid Dose | EXPERIMENTAL | A mid dose of LX3305; daily oral intake for 12 weeks |
| High Dose | EXPERIMENTAL | A high dose of LX3305; daily oral intake for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Matching placebo dosing with daily oral intake for 12 weeks |
| 50 mg LX3305 QD | EXPERIMENTAL | - |
| 100 mg LX3305 QD | EXPERIMENTAL | - |
| 150 mg LX3305 QD | EXPERIMENTAL | - |
| 200 mg LX3305 QD | EXPERIMENTAL | - |
| 250 mg LX3305 QD | EXPERIMENTAL | - |
| 300 mg LX3305 QD | EXPERIMENTAL | - |
| 400 mg LX3305 QD | EXPERIMENTAL | - |
| 250 mg LX3305 BID | EXPERIMENTAL | - |
| 500 mg LX3305 QD | EXPERIMENTAL | - |
| LX3305 | EXPERIMENTAL | Daily oral intake of LX3305 for 14 days. |
| LX3305 Placebo | PLACEBO_COMPARATOR | Matching placebo dosing with daily oral intake for 14 days. |
| Name | Type | Description |
|---|---|---|
| LX3305 low dose | DRUG | A low dose of LX3305; daily oral intake for 12 weeks |
| LX3305 mid dose | DRUG | A mid dose of LX3305; daily oral intake for 12 weeks |
| LX3305 high dose | DRUG | A high dose of LX3305; daily oral intake for 12 weeks |
| Placebo | DRUG | Matching placebo dosing with daily oral intake for 12 weeks |
| 50 mg LX3305 QD | DRUG | 50 mg LX3305 once daily in capsule form |
| 100 mg LX3305 QD | DRUG | 100 mg LX3305 once daily in capsule form |
| 150 mg LX3305 QD | DRUG | 150 mg LX3305 once daily in capsule form |
| 200 mg LX3305 QD | DRUG | 200 mg LX3305 once daily in capsule form |
| 250 mg LX3305 QD | DRUG | 250 mg LX3305 once daily in capsule form |
| 300 mg LX3305 QD | DRUG | 300 mg LX3305 once daily in capsule form |
| 400 mg LX3305 QD | DRUG | 400 mg LX3305 once daily in capsule form |
| 250 mg LX3305 BID | DRUG | 250 mg LX3305 twice daily in capsule form |
| 500 mg LX3305 QD | DRUG | 500 mg LX3305 once daily in capsule form |
| LX3305 | DRUG | Daily oral intake of LX3305 for 14 days. |
| LX3305 Placebo | DRUG | Matching placebo dosing with daily oral intake for 14 days. |
| Methotrexate | DRUG | Once weekly stable-dose methotrexate. |
Inclusion Criteria: * Males and females aged 18-75 years old * Rheumatoid arthritis present for at least 6 months, functional class I, II, or III as defined by ACR criteria * Active disease as determined by the presence of ≥6 swollen joints, ≥6 tender joints, and serum C-reactive protein level \> u...
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LX3305 is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is studied in combination with methotrexate in patients with stable or active disease. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
LX3305 is being developed by Lexicon Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker LXRX. The company is conducting clinical trials to evaluate the safety and efficacy of LX3305 in patients with rheumatoid arthritis.
LX3305 is in Phase 2 clinical development for rheumatoid arthritis. Three clinical trials have been completed, including two Phase 1 studies and one Phase 2 study. The drug remains investigational and has not received FDA approval.
LX3305 has been studied in three completed clinical trials: NCT00847886, a Phase 1 study of LX3305 with methotrexate in stable rheumatoid arthritis; NCT00903383, a Phase 2 study in active rheumatoid arthritis on stable methotrexate; and NCT01417052, a Phase 1 safety and efficacy study in active rheumatoid arthritis.
LX3305 is the sole name provided for this investigational drug. No alternative names or brand names have been disclosed. It is a small molecule being developed by Lexicon Pharmaceuticals for rheumatoid arthritis.