Ixekizumab in the Treatment of Bullous Pemphigoid
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|ClinicalTrials.gov Identifier: NCT03099538|
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : December 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bullous Pemphigoid Pemphigoid||Drug: Ixekizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single center, exploratory, open-label, single-arm design study of 12 patients with BP. Treatment naïve and treatment refractory patients with BP will be treated with Ixekizumab. Patients who are non-responders, to physician choice standard of care, will undergo a washout period and will be enrolled in the study.|
|Masking:||None (Open Label)|
|Official Title:||Ixekizumab in the Treatment of Bullous Pemphigoid|
|Actual Study Start Date :||August 15, 2017|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.
Other Name: Taltz
- Cessation of blister formation [ Time Frame: Up to 12 weeks ]Median time to cessation of blister formation during the 12 weeks of therapy.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099538
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259|
|Contact: Narcelle Jean-Louis 480-301-4714 firstname.lastname@example.org|
|Principal Investigator:||Aaron Mangold, MD||Mayo Clinic|