Clinical Trials

Each of the CombinatoRx product candidates is specifically chosen for clinical study to potentially provide an important therapeutic benefit for a serious disease through the synergistic combination of its components.
CombinatoRx has a number of product candidates in various stages of human clinical trials. For information about CombinatoRx clinical trials please contact clinicaltrials@combinatorx.com.
None of the CombinatoRx product candidates, including CRx-102, is approved by the FDA or any other regulatory body for the treatment of diseases.
Upcoming Clinical Research Opportunities in osteoarthritis and rheumatoid arthritis
- CRx-102: A Novel Synergistic Combination Product Candidate
  - CRx-102 is an oral synergistic combination drug candidate containing the cardiovascular agent dipyridamole and an unconventionally low dose of the glucocorticoid prednisolone.
  - CRx-102 works through a novel mechanism of action in which dipyridamole selectively amplifies prednisolone's anti-inflammatory and immuno-modulatory activities without replicating its side effects.
  - CRx-102 is administered in a proprietary modified release co-formulation designed to optimize the anti-inflammatory synergy between the components and improve tolerability.
- Phase 2b Osteoarthritis of the Knee Clinical Trial
  - Objectives
    - To assess the efficacy of CRx-102 in Knee OA using WOMAC
    - To assess the safety and tolerability of CRx-102
  - Overview
    - Phase 2, randomized, double-blind, placebo-controlled 98 day study with 1 year safety extension for eligible subjects
    - Flare design: Pain >3 out of 10 on a VAS scale at enrollment; pain increases by 1 point with NSAID withdrawal
    - ~250 subjects at ~35 sites in Canada and U.S.
  - Inclusion criteria
    - Knee pain for at least six months requiring NSAIDs/Coxibs
    - Radiographic evidence of Knee OA (Kellgren and Lawrence grade 2 or 3)
  - Contact: clinicaltrials@combinatorx.com
- Phase 2b Rheumatoid Arthritis Clinical Trial
  - Objectives
    - To assess the efficacy of CRx-102 in subjects on stable DMARDs with active rheumatoid arthritis
    - To assess the safety and tolerability of CRx-102
  - Overview
    - Phase 2b; randomized, double-blind, placebo-controlled 98 day study with 1 year safety extension for eligible subjects
    - ~600 subjects at ~100 sites in Canada, U.S., Europe, and South America
  - Inclusion criteria
    - At least 4 swollen and 6 tender joints
    - C-reactive protein greater than upper limit of normal
    - Any DMARD for at least 3 months, stable dose for at least 6 weeks prior to screening if methotrexate 7.5 mg/wk
  - Contact: clinicaltrials@combinatorx.com