Ixekizumab in the Treatment of Bullous Pemphigoid
|ClinicalTrials.gov Identifier: NCT03099538|
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : May 8, 2020
Last Update Posted : May 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bullous Pemphigoid Pemphigoid||Drug: Ixekizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 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|
|Actual Primary Completion Date :||June 6, 2019|
|Actual Study Completion Date :||June 6, 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 ]The change in Bullous Pemphigoid Disease Activity Index (BPDAI) from week 0 to 12 of treatment will be measured.The BPDAI is a standard scoring system for cutaneous disease activity and pruritus in BP. BPDAI is predictive of the likelihood of a subsequent flare. The BPDAI consists of scoring various types of lesions and creates a score ranging from 0 to 120. A score of greater than 56 is considered severe disease.
- 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 (AE) will be reported per the Common Terminology Criteria for Adverse Events (CTCAEv4.0), a descriptive terminology which can be utilized for AE reporting. A grading (severity) scale is provided for each AE Grade refers to the severity of the AE. The CTCAE displays Grades 1-5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
- 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|
|Principal Investigator:||Aaron Mangold, MD||Mayo Clinic|