Trial · NCT03099538
Ixekizumab in the Treatment of Bullous Pemphigoid
NCT03099538, Phase 2, Completed, Mayo Clinic; results first posted 2020-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ixekizumab in the Treatment of Bullous Pemphigoid. Trials, record NCT03099538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03099538
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ixekizumab in the Treatment of Bullous Pemphigoid
- NCT number
- NCT03099538
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Bullous Pemphigoid, Pemphigoid
- Interventions
- Ixekizumab
- First posted
- 2017-04-04
- Last updated
- 2020-05-21
- Results first posted
- 2020-05-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cessation of Blister Formation | Up to 12 weeks | Median time to cessation of blister formation during the 12 weeks of therapy. |
| Secondary | Change in Bullous Pemphigoid Disease Activity Index (BPDAI) | 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. |
| Secondary | Prednisone Dose (mg) | 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. |
| Secondary | Number of Participants With Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0). | 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. |
| Secondary | Decrease in Immunoglobulin G Anti-Bullous Pemphigoid 180 and 230 Antibody (Anti-BP180 & 230 IgG) | 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) |
| Secondary | Decrease in Neutrophil and Eosinophil Counts | 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) |
| Secondary | Change in Multiplex Cytokine Analysis | 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). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cessation of Blister Formation | Up to 12 weeks | Endpoint was not achieved as there was no cession of blisters. | days | MEDIAN |
| SECONDARY | Change in Bullous Pemphigoid Disease Activity Index (BPDAI) | Week 0 and week 12 | units on a scale | MEAN | |
| SECONDARY | Prednisone Dose (mg) | Epoch 1 (washout- up to 4 weeks) Epoch 2 (week 0 to week 12) Epoch 3 (week 12 to week 16) | Only one subject remained in the study by Epoch 3 timepoint (week 12 to 16) | mg/d | MEAN |
| SECONDARY | Number of Participants With Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0). | weeks 0 to 18 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Decrease in Immunoglobulin G Anti-Bullous Pemphigoid 180 and 230 Antibody (Anti-BP180 & 230 IgG) | week 0, 4, 8, 12 | This outcome measure was not achieved due to lack to sample to run assays. | ||
| SECONDARY | Decrease in Neutrophil and Eosinophil Counts | week 0, 4, 8, 12 | This outcome measure was not achieved due to lack of data. | ||
| SECONDARY | Change in Multiplex Cytokine Analysis | week 0, 4, 8, 12 | This outcome measure was not achieved due to lack of sample to run assays. |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cessation of Blister Formation | Ixekizumab | NA | Standard Deviation NA | days | |
| Change in Bullous Pemphigoid Disease Activity Index (BPDAI) | Ixekizumab | Week 0 | 24.8 | Standard Deviation 17.71 | units on a scale |
| Change in Bullous Pemphigoid Disease Activity Index (BPDAI) | Ixekizumab | Week 12 | 39 | Standard Deviation 24.48 | units on a scale |
| Prednisone Dose (mg) | Ixekizumab | Epoch 1 | 0 | Standard Deviation 0 | mg/d |
| Prednisone Dose (mg) | Ixekizumab | Epoch 2 | 15.42 | Standard Deviation 9.17 | mg/d |
| Prednisone Dose (mg) | Ixekizumab | Epoch 3 | 0 | Standard Deviation 0 | mg/d |
| Number of Participants With Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0). | Ixekizumab | 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). | Ixekizumab | 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). | Ixekizumab | 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). | Ixekizumab | Grade 4 | 0 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ixekizumab | 4 | |
| Overall Study | COMPLETED | Ixekizumab | 1 | |
| Overall Study | NOT COMPLETED | Ixekizumab | 3 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rib pain | General disorders | Ixekizumab | 1 | 4 | 1 |
| other | Skin Pain | General disorders | Ixekizumab | 1 | 4 | 1 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Ixekizumab | 2 | 4 | 2 |
| other | Conjunctivitis | Eye disorders | Ixekizumab | 1 | 4 | 1 |
| other | Dry eyes | Eye disorders | Ixekizumab | 1 | 4 | 1 |
| other | Headache | General disorders | Ixekizumab | 1 | 4 | 1 |
| other | Shortness of breath | Respiratory, thoracic and mediastinal disorders | Ixekizumab | 1 | 4 | 1 |
| other | Staphylococcal overgrowth | Infections and infestations | Ixekizumab | 1 | 4 | 1 |
| other | Facial swelling | General disorders | Ixekizumab | 1 | 4 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ixekizumab | 0 | 4 |
| Total, other adverse events | Ixekizumab | 4 | 4 |
| Total, serious adverse events | Ixekizumab | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03099538
GET https://conductscience.org/api/trials/v1/NCT03099538/registered