Lupus Drugs Clinical Trials

Lupus Overview

Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissue. The different types of the disease covered in the tracker include systemic lupus erythematosus (SLE), discoid lupus erythematosus (DLE), cutaneous lupus erythematosus (CLE), lupus nephritis and lupus vulgaris.

Several drugs, including anti-inflammatory drugs (aspirin and acetaminophen), non-steroidal anti-inflammatory drugs (NSAIDs) (ibuprofen, naproxen, indomethacin, nabumetone and celecoxib), corticosteroids (prednisone, prednisolone and methylprenisolone), antimalarials (chloroquine and hydroxychloroquine), immunosuppressive drugs (cyclophosphamide, methotrexate and azathioprine), and anticoagulants (low-dose aspirin, heparin and warfarin), are used for the treatment of the various symptoms associated with lupus. Benlysta®, co-developed by Human Genome Sciences and GSK, is the first and only drug to be specifically developed and approved for the treatment of lupus. Prior to Benlysta®’s approval in 2011, Plaquenil® (hydroxychloroquine) and corticosteroids, which were approved by the USFDA in 1955, were the only drugs available for lupus. Benlysta® is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active, autoantibody-positive SLE, who are receiving standard therapy

In addition to Benlysta®, H.P. Acthar® Gel (repository corticotropin injection) is approved by the USFDA for use during an exacerbation or as a maintenance therapy in selected cases of SLE. Cellcept® (mycophenolate mofetil), Mizoribine® (bredinin), and Prograf® (tacrolimus) are drugs approved for the treatment of lupus in Japan.

Amongst the therapies being developed for lupus, the trend is shifting from conventional small molecule drugs towards the development of biologics and novel treatment options, such as mesenchymal stem cells.

Scope of the Report

The primary objective of this report was to capture details on the various clinical trials that are currently underway in the field of lupus. We have identified a number of lupus drugs for various indications, including SLE, CLE, DLE, lupus nephritis and lupus vulgaris, and clinical trials that are either being conducted or are planned to be conducted for each of these drugs. For each specific product, we have provided the following information:

1. Name of Primary Drug
2. Mechanism of Action
3. Indication (in highest phase of development)
4. Highest Phase of Development
5. Route of Administration (in highest phase of development)
6. Originator
7. Developer / Licensee
8. Type of Developer

For each specific trial, wehave provided thefollowing information:

1. Identity of Sponsor / Collaborator
2. Type of Sponsor
3. Trial Title
4. Trial Objective
5. Trial Phase
6. Trial Status
7. Start Date
8. End Date
9. Enrolment
10. Age Group
11. Age Range
12. Inclusion Criteria
13. Exclusion Criteria
14. Allocation (Randomized / Non-Randomized)
15. Masking (Single Blind / Double Blind / Open Label)
16. Intervention Model (Parallel / Single Group / Crossover/ Factorial)
17. Endpoint
18. Primary Endpoint
19. Secondary Endpoint
20. Treatment Arms
21. Route of Administration
22. Trial Location
23. Study Director
24. Principle Investigator
25. Primary Trial Identifier
26. Other Identifiers
27. Trial Results (if any)

The above information mentioned has been presented in the form a dashboard to provide a high level view of the ongoing activity in this space.