Trial Outcomes & Findings for Ixekizumab in the Treatment of Bullous Pemphigoid (NCT NCT03099538)
NCT ID: NCT03099538
Last Updated: 2020-05-21
Results Overview
Median time to cessation of blister formation during the 12 weeks of therapy.
COMPLETED
PHASE2
4 participants
Up to 12 weeks
2020-05-21
Participant Flow
Participant milestones
| Measure |
Ixekizumab
Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.
Ixekizumab: Subcutaneous injection
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Ixekizumab
Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.
Ixekizumab: Subcutaneous injection
|
|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
Baseline Characteristics
Ixekizumab in the Treatment of Bullous Pemphigoid
Baseline characteristics by cohort
| Measure |
Ixekizumab
n=4 Participants
Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.
Ixekizumab: Subcutaneous injection
|
|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 6.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Endpoint was not achieved as there was no cession of blisters.
Median time to cessation of blister formation during the 12 weeks of therapy.
Outcome measures
| Measure |
Ixekizumab
n=4 Participants
Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.
Ixekizumab: Subcutaneous injection
|
|---|---|
|
Cessation of Blister Formation
|
NA days
Standard Deviation NA
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Week 0 and week 12The 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.
Outcome measures
| Measure |
Ixekizumab
n=4 Participants
Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.
Ixekizumab: Subcutaneous injection
|
|---|---|
|
Change in Bullous Pemphigoid Disease Activity Index (BPDAI)
Week 0
|
24.8 units on a scale
Standard Deviation 17.71
|
|
Change in Bullous Pemphigoid Disease Activity Index (BPDAI)
Week 12
|
39 units on a scale
Standard Deviation 24.48
|
SECONDARY outcome
Timeframe: Epoch 1 (washout- up to 4 weeks) Epoch 2 (week 0 to week 12) Epoch 3 (week 12 to week 16)Population: Only one subject remained in the study by Epoch 3 timepoint (week 12 to 16)
Average daily prednisone dose (mg) will be calculated for each Epoch.
Outcome measures
| Measure |
Ixekizumab
n=4 Participants
Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.
Ixekizumab: Subcutaneous injection
|
|---|---|
|
Prednisone Dose (mg)
Epoch 1
|
0 mg/d
Standard Deviation 0
|
|
Prednisone Dose (mg)
Epoch 2
|
15.42 mg/d
Standard Deviation 9.17
|
|
Prednisone Dose (mg)
Epoch 3
|
0 mg/d
Standard Deviation 0
|
SECONDARY outcome
Timeframe: weeks 0 to 18The 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.
Outcome measures
| Measure |
Ixekizumab
n=4 Participants
Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.
Ixekizumab: Subcutaneous injection
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
Grade 1
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
Grade 2
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
Grade 3
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
Grade 4
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
Grade 5
|
0 Participants
|
SECONDARY outcome
Timeframe: week 0, 4, 8, 12Population: This outcome measure was not achieved due to lack to sample to run assays.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, 4, 8, 12Population: This outcome measure was not achieved due to lack of data.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, 4, 8, 12Population: This outcome measure was not achieved due to lack of sample to run assays.
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).
Outcome measures
Outcome data not reported
Adverse Events
Ixekizumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ixekizumab
n=4 participants at risk
Ixekizumab subcutaneous 160mg week 0, 80mg weeks 2, 4, 6, 8, 10, 12.
Ixekizumab: Subcutaneous injection
|
|---|---|
|
General disorders
Rib pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from baseline until 30 days post-study participation, for a total of approximately four to five months.
|
|
General disorders
Skin Pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from baseline until 30 days post-study participation, for a total of approximately four to five months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
2/4 • Number of events 2 • Adverse events were collected for each subject from baseline until 30 days post-study participation, for a total of approximately four to five months.
|
|
Eye disorders
Conjunctivitis
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from baseline until 30 days post-study participation, for a total of approximately four to five months.
|
|
Eye disorders
Dry eyes
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from baseline until 30 days post-study participation, for a total of approximately four to five months.
|
|
General disorders
Headache
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from baseline until 30 days post-study participation, for a total of approximately four to five months.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from baseline until 30 days post-study participation, for a total of approximately four to five months.
|
|
Infections and infestations
Staphylococcal overgrowth
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from baseline until 30 days post-study participation, for a total of approximately four to five months.
|
|
General disorders
Facial swelling
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from baseline until 30 days post-study participation, for a total of approximately four to five months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place