Rheumatoid Arthritis (RA) MedDRA version: 12.0 Level: LLT Classification code 10039073 Term:
Conditions
Interventions
Product Name: LX3305 Dihydrate
Product Code: LX3305
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: None as of yet
CAS Number: 1078151-47-9
Current Sponsor code: LX3305 Dihydrate
Other descrip
Sponsors
Lexicon Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria at screening to be considered eligible for participation in the study: 1. Adult subjects, aged >18 years and ULN 5. Treated with MTX for at least 6 months (7.5 to 25 mg/week) prior to screening, and currently receiving a stable dose of MTX (>10 mg/week) and with a stable route of administration, as well as folate supplementation. Both MTX and folate supplementation must be stable for at least 8 weeks prior to Day 1, and they should remain stable throughout study participation. 6. If taking NSAIDs, steroids, minocycline, or doxycycline, must be on stable regimen for 6 weeks prior to Day 1 (oral steroid dose must be =10 mg prednisone per day, or equivalent) 7. If taking hydroxychloroquine or sulfasalazine, must be on a stable regimen for 12 weeks prior to Day 1 8. Ability to give written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria at screening will be excluded from participation in the study: 1. Women who are pregnant or nursing 2. RA diagnosis prior to 16 years of age (Juvenile RA) 3. Subjects who have demonstrated lack of response to >3 DMARDs, or subjects who have been exposed to >1 biologic DMARD 4. Use of DMARDs, other than MTX and those defined in the Inclusion Criteria, within 12 weeks prior to Day 1 5. Use of leflunomide within 4 weeks, or use of biologic DMARDs within 12 weeks, prior to Day 1, with the exception of rituximab or other B-cell depleting therapies, which cannot be used within 12 months prior to Day 1 6. Intra-articular and/or parenteral corticosteroids within 4 weeks prior to Day 1 7. Receipt of live vaccine within 4 weeks prior to Day 1 8. Major surgical procedure within 8 weeks prior to Day 1 9. Blood donation within 4 weeks prior to Day 1 10. Any systemic inflammatory condition that may interfere with the interpretation of outcome data 11. Recurrent infections, or presence of current infection within 2 weeks prior to Day 1, other than onychomycosis 12. History of bleeding diathesis 13. History of medically significant opportunistic infection 14. History of drug or alcohol abuse within 3 years prior to Day 1 15. History of cancer within 5 years prior to Day 1, other than resected basal cell carcinoma 16. Presence of hepatic or biliary disease, including symptomatic cholelithiasis 17. History of tuberculosis 18.Positive result for purified protein derivative (PPD) skin test, defined as >5 mm of induration. If a subject exhibits a positive PPD test, but prior immunization with Bacille Calmette Guerin (BCG) vaccine can be ascertained, a repeat test withQuantiferon-TB, in conjunction with a normal chest X-ray taken within 6 months prior to screening, may be used to establish eligibility 19. History of human immunodeficiency virus (HIV) 20. Abnormal laboratory results meeting the following criteria: a. Hemoglobin 1.5 x ULN e. Alkaline phosphatase (ALP) >1.5 x ULN f. Presence of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb) g. Microscopic hematuria 21. Any other clinically significant laboratory test results, ECG, X-ray, medical condition, or unspecified reason that, in the opinion of the investigator, make the subject unsuitable for enrollment 22. Previous exposure to LX3305 23. Use of any other investigational agent or participation in an investigational trial within 30 days prior to Day 1, or use of an investigational biologic agent within 90 days, or less than five half-lives, prior to Day 1 24. Inability to communicate or cooperate with the investigator for any reason, or inability to attend visits as outlined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are: • To evaluate the safety and tolerability of three dose levels of LX3305 over 12 weeks in subjects with active RA who are also receiving stable doses of MTX; • To evaluate the efficacy of three dose levels of LX3305 by utilizing the American College of Rheumatology 20% response criteria (ACR20) at 12 weeks in subjects with active RA who are also receiving stable doses of MTX.;Secondary Objective: The secondary objectives of this study are: • To evaluate the efficacy of three dose levels of LX3305 over time by utilizing the ACR 20%, 50%, and 70% response criteria (ACR20, ACR50, and ACR70, respectively) in subjects with active RA who are also receiving stable doses of MTX; • To evaluate the efficacy of three dose levels of LX3305 over time by utilizing the Hybrid ACR response measure in subjects with active RA who are also receiving stable doses of MTX; • To evaluate the efficacy of three dose levels of LX3305 by Disease Activity Score in 28 joints (DAS28) at 12 weeks in subjects with active RA who are also receiving stable doses of MTX; • To evaluate the efficacy of three dose levels of LX3305 by change from baseline over time in Disease Activity Score in 28 joints (DAS28) in subjects with active RA who are also receiving stable doses of MTX. ;Primary end point(s): 1. Efficacy Endpoints The primary efficacy endpoint is the proportion of subjects achieving an ACR20 response at Week 12. The secondary efficacy endpoints are: • Proportion of subjects achieving ACR20/50/70 responses at Weeks 4, 8, 12, and 14 • Mean Hybrid ACR response measure at Weeks 4, 8, 12, and 14 • Proportion of subjects determined to be European League Against Rheumatism (EULAR) responders with good and moderate responses to treatment as measured by DAS28 score, and change from baseline in DAS28 score, at Weeks 4, 8, 12, and 14 • Proportion of subjects determined to have low disease activity as measured by DAS28 score at Weeks 4, 8, 12, and 1 | — |
Countries
Bulgaria, Czech Republic, Hungary
Outcome results
None listed