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Also known as LX3305 low dose
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 studied for the treatment of rheumatoid arthritis, an inflammatory joint disease. It has been evaluated in clinical trials in adults with active rheumatoid arthritis, including patients receiving stable methotrexate. LX3305 is not approved and remains in clinical development.
LX3305 is being developed by Lexicon Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker LXRX. The company sponsored the clinical trials evaluating LX3305 in rheumatoid arthritis.
LX3305 has reached Phase 2 development for rheumatoid arthritis. The Phase 2 trial, NCT00903383, enrolled 208 patients with active rheumatoid arthritis on stable methotrexate. All three listed LX3305 trials are completed, and no trials are currently active.
Three completed trials have studied LX3305 in rheumatoid arthritis: NCT00903383, a Phase 2 study of 208 patients with active disease on stable methotrexate across the United States, Bulgaria, Czechia, Hungary, Poland and Serbia; NCT01417052, a Phase 1 study of 10 patients; and NCT00847886, a Phase 1 study of 15 patients combining LX3305 with methotrexate.
The LX3305 trials were randomized, double-blind and placebo-controlled, enrolling a total of 233 participants across three completed studies. All trials enrolled adults aged 18 years and older with rheumatoid arthritis, and participants were not healthy volunteers. The Phase 2 trial tested LX3305 in patients on stable methotrexate.