Clinical Trial: Ixekizumab in the Treatment of Bullous Pemphigoid

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Ixekizumab in the Treatment of Bullous Pemphigoid

Brief Summary: Recently, Interleukin (IL)-17 has been identified as a key driver of chronic inflammation in Bullous Pemphigoid (BP). Ixekizumab is a recombinant high-affinity fully human monoclonal antibody that targets IL-17A Immunoglobulin gamma-1 (IgG1)/kappa-class. The purpose of this study is to determine the effect of Ixekizumab on BP patients.

Detailed Summary: BP is the most common auto-immune blistering disease of the skin and causes significant morbidity. BP disproportionally affects the elderly population and the current, non-specific immunosuppressive therapies, in addition to patient comorbidities, are associated with a high risk of infection related mortality. Neutrophils and their proteases have been shown to play a major role in the cleavage of Bullous Pemphigoid 180 Antigen (BP180) in BP. Mast cells and other cellular mediators also contribute to the pro-inflammatory environment within and surrounding blisters of BP. However, the prior targeting of mast cells and basophils has resulted in unpredictable disease control. Recently, IL-17 has been identified as a key driver of chronic inflammation in BP. With the increasing aged population in the United States, BP will increase in prevalence and the development of a more targeted approach will be necessary to decrease morbidity and mortality. IL-17 inhibition with Ixekizumab may have targeted, disease-modifying effects on BP. The primary objective is to test the effect of Ixekizumab in the treatment of the autoimmune blistering disease, BP.
Sponsor: Mayo Clinic

Current Primary Outcome: Cessation of blister formation [ Time Frame: Up to 12 weeks ]

Median time to cessation of blister formation during the 12 weeks of therapy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Bullous Pemphigoid Disease Activity Index (BPDAI) [ Time Frame: Week 0 and week 12 ]
    Change in Bullous Pemphigoid Disease Activity Index (BPDAI) from week 0 to 12 of treatment.
  • Prednisone Dose (mg) [ Time Frame: Epoch 1 (washout- up to 4 weeks) Epoch 2 (week 0 to week 12) Epoch 3 (week 12 to week 16) ]
    Average daily prednisone dose (mg) will be calculated for each Epoch.
  • Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). [ Time Frame: weeks 0 to 18 ]
    The clinical safety of Ixekizumab will be monitored with collection of vital signs, clinical examination, and clinical laboratory studies. Adverse events will be reported per the CTCAEv4.0.
  • Decrease in Immunoglobulin G Anti-Bullous Pemphigoid 180 and 230 Antibody (Anti-BP180 & 230 IgG) [ Time Frame: week 0, 4, 8, 12 ]
    We will measure the anti-BP180&230 antibodies through out treatment. These assays will be completed using and ELISA assay. Mayo medical labs references for anti-BP180&230 (<9.0 Units negative, > or = 9.0 Units positive)
  • Decrease in Neutrophil and Eosinophil counts [ Time Frame: week 0, 4, 8, 12 ]
    Neutrophil and eosinophil counts will be monitored throughout therapy. Mayo medical labs reports normal neutrophil levels (1.70-7.00X10(9)/L) and normal eosinophil levels (0.05-0.5X10(9)/L)
  • Change in multiplex cytokine analysis [ Time Frame: week 0, 4, 8, 12 ]
    Multiplex cytokine analysis will be performed throughout therapy on Interleukin (IL)- 6, 17, 22, 23, Transforming growth factor beta (TGFb), and matrix-metalloprotease-9 (MMP9).


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: March 21, 2017
Date Started: April 2017
Date Completion: December 2018
Last Updated: April 4, 2017
Last Verified: April 2017