Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00903383 | Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate | PHASE2 | COMPLETED | 208 | — | — | Jul 1, 2009 | - | Dec 15, 2011 | 38 | United States, Bulgaria +4 |
| NCT01417052 | A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid Arthritis | PHASE1 | COMPLETED | 10 | — | — | Sep 1, 2011 | Jun 1, 2012 | Aug 2, 2012 | 1 | United States |
| NCT00847886 | Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis | PHASE1 | COMPLETED | 15 | — | — | Feb 1, 2009 | Mar 1, 2009 | Jun 3, 2010 | 1 | United States |
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...