Trial · NCT02226146
Evaluation of Safety, Efficacy and Pharmacodynamic Effect of Bertilimumab in Patients With Bullous Pemphigoid
NCT02226146, Phase 2, Completed, Alexion Pharmaceuticals, Inc.; results first posted 2025-11-26
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Evaluation of Safety, Efficacy and Pharmacodynamic Effect of Bertilimumab in Patients With Bullous Pemphigoid. Trials, record NCT02226146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02226146
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Safety, Efficacy and Pharmacodynamic Effect of Bertilimumab in Patients With Bullous Pemphigoid
- NCT number
- NCT02226146
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- Pemphigoid, Bullous
- Interventions
- Bertilimumab
- First posted
- 2014-08-27
- Last updated
- 2025-11-26
- Results first posted
- 2025-11-26
- Limitations and caveats
- Study conducted by Immune Pharmaceuticals Inc. and was acquired by Alexion Pharmaceuticals, Inc after study completion, database lock, and report generation.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Anti-Drug Antibodies | Baseline up to 1 year | |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline up to 1 year | An AE is any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study treatment. TEAEs were defined as AEs that started on or after the first administration of study drug until the end of the follow up period. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. |
| Secondary | Number of Participants Who Achieved at Least 50%, 70% and 90% Reduction From Baseline in Total Activity Score of the Bullous Pemphigoid Disease Area Index (BPDAI) Score | Baseline, Day 84 | BPDAI is a clinician completed tool that is used for independent disease severity assessment to measure disease extent in bullous pemphigoid. The total BPDAI activity score was calculated as the arithmetic sum of the 3 subcomponents - cutaneous blisters/erosions, cutaneous urticaria/erythema, and mucosal blisters/erosions. The BPDAI total activity gives an indication of disease activity, with score range from 0 (no disease activity) to 360 (severe disease activity). Higher scores indicated greater disease activity. Baseline was defined as the last measurement obtained before the treatment initiation. |
| Secondary | Number of Participants Who Had Tapered to Prednisone Dose of ≤ 10 mg/Day | Baseline, Day 84 | |
| Secondary | Percentage of Reduction From Baseline in BPDAI Pruritis (Visual Analogue Scale [VAS]) Total Score | Baseline, Day 84 | The VAS sub-scores were defined as: 1. VAS Sub-Score I: How severe has your itching been over the last 24 hours. 2. VAS Sub-Score II: How severe has your itching been over the past week. 3. VAS Sub-Score III: How severe has your itching been over the past month. The Total Pruritus VAS score was defined as the sum over the three sub-scores. If at least one of the sub-scores is missing, the total is not defined. If value for the pruritus total score could not be determined than the value was left as blank for the calculation of the mean. Scores for the BPDAI-VAS ranged from 0 to 30, with higher scores indicating a worse condition. |
| Secondary | Percentage of Reduction From Baseline in Autoimmune Bullous Diseases Quality of Life (ABQOL) Total Score | Baseline, Day 84 | ABQoL questionnaire assessed the impact of autoimmune bullous disease and their therapies on the daily life of participants. Scores range from 0 to 51 with a higher score representing a worse quality of life. If value for the ABQOL total score could not be determined than the value was left as blank for the calculation of the mean. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Anti-Drug Antibodies | Baseline up to 1 year | The Safety analysis population consisted of all participants enrolled in the trial who received at least one infusion of bertilimumab 10 mg/kg. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline up to 1 year | The Safety analysis population consisted of all participants enrolled in the trial who received at least one infusion of bertilimumab 10 mg/kg. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved at Least 50%, 70% and 90% Reduction From Baseline in Total Activity Score of the Bullous Pemphigoid Disease Area Index (BPDAI) Score | Baseline, Day 84 | The Efficacy population included all participants in the safety population who had the visit score on the BPDAI at baseline and at least one post baseline BPDAI score. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Had Tapered to Prednisone Dose of ≤ 10 mg/Day | Baseline, Day 84 | The Efficacy population included all participants in the safety population who had the visit score on the BPDAI at baseline and at least one post baseline BPDAI score. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Reduction From Baseline in BPDAI Pruritis (Visual Analogue Scale [VAS]) Total Score | Baseline, Day 84 | The Efficacy population included all participants in the safety population who had the visit score on the BPDAI at baseline and at least one post baseline BPDAI score. | percentage of reduction in BPDAI VAS | MEAN |
| SECONDARY | Percentage of Reduction From Baseline in Autoimmune Bullous Diseases Quality of Life (ABQOL) Total Score | Baseline, Day 84 | The Efficacy population included all participants in the safety population who had the visit score on the BPDAI at baseline and at least one post baseline BPDAI score. | percentage of reduction in ABQOL score | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Anti-Drug Antibodies | Bertilimumab + Prednisone | 0 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Bertilimumab + Prednisone | 6 | Participants | ||
| Number of Participants Who Achieved at Least 50%, 70% and 90% Reduction From Baseline in Total Activity Score of the Bullous Pemphigoid Disease Area Index (BPDAI) Score | Bertilimumab + Prednisone | 50% Reduction | 6 | Participants | |
| Number of Participants Who Achieved at Least 50%, 70% and 90% Reduction From Baseline in Total Activity Score of the Bullous Pemphigoid Disease Area Index (BPDAI) Score | Bertilimumab + Prednisone | 70% Reduction | 5 | Participants | |
| Number of Participants Who Achieved at Least 50%, 70% and 90% Reduction From Baseline in Total Activity Score of the Bullous Pemphigoid Disease Area Index (BPDAI) Score | Bertilimumab + Prednisone | 90% Reduction | 4 | Participants | |
| Number of Participants Who Had Tapered to Prednisone Dose of ≤ 10 mg/Day | Bertilimumab + Prednisone | 5 | Participants | ||
| Percentage of Reduction From Baseline in BPDAI Pruritis (Visual Analogue Scale [VAS]) Total Score | Bertilimumab + Prednisone | 8.6 | Full Range 3 to 19 | percentage of reduction in BPDAI VAS | |
| Percentage of Reduction From Baseline in Autoimmune Bullous Diseases Quality of Life (ABQOL) Total Score | Bertilimumab + Prednisone | 11 | Full Range 1 to 39 | percentage of reduction in ABQOL score |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bertilimumab + Prednisone | 11 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Bertilimumab + Prednisone | 9 | |
| Overall Study | COMPLETED | Bertilimumab + Prednisone | 8 | |
| Overall Study | NOT COMPLETED | Bertilimumab + Prednisone | 3 |
Source ClinicalTrials.gov
Adverse events10
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 | Blurred vision | Eye disorders | Bertilimumab + Prednisone | 1 | 9 | |
| other | Traumatic laceration right big toe | Injury, poisoning and procedural complications | Bertilimumab + Prednisone | 1 | 9 | |
| other | Upper respiratory tract infection | Infections and infestations | Bertilimumab + Prednisone | 1 | 9 | |
| other | Night sweating | Reproductive system and breast disorders | Bertilimumab + Prednisone | 1 | 9 | |
| other | Edema (bilateral) | General disorders | Bertilimumab + Prednisone | 1 | 9 | |
| other | Muscle cramps | Musculoskeletal and connective tissue disorders | Bertilimumab + Prednisone | 1 | 9 | |
| other | Fall | Injury, poisoning and procedural complications | Bertilimumab + Prednisone | 1 | 9 | |
| other | Gamma-Glutamyl Transferase increased | Hepatobiliary disorders | Bertilimumab + Prednisone | 1 | 9 | |
| other | Cyst at base of tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Bertilimumab + Prednisone | 1 | 9 | |
| serious | Peripheral vascular disorder | Vascular disorders | Bertilimumab + Prednisone | 1 | 9 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bertilimumab + Prednisone | 0 | 9 |
| Total, other adverse events | Bertilimumab + Prednisone | 6 | 9 |
| Total, serious adverse events | Bertilimumab + Prednisone | 1 | 9 |
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/NCT02226146
GET https://conductscience.org/api/trials/v1/NCT02226146/registered