Trial · NCT01688882
Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment
NCT01688882, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2016-04-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment. Trials, record NCT01688882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01688882
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment
- NCT number
- NCT01688882
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Bullous Pemphigoid
- Interventions
- QGE031, Placebo
- First posted
- 2012-09-20
- Last updated
- 2016-04-28
- Results first posted
- 2016-04-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients That Had a Clinical Global Assessment of Change (CGA-C) Responder Rate by Week 12 | 12 weeks | Clinical Global Assessment of Change (CGA-C) responder rate was the responder rate at 12 weeks based on the CGA-C in bullous pemphigoid (BP). A patient with a CGA-C score of 3 or 4 indicating 'at least marked improvement from baseline' at 12 weeks was considered a responder. The CGA-C is an investigator assessment of change from baseline and is scored as follows: -4 = Very marked worsening (100% worsening); -3 = Marked worsening (67-99% worsening); -2 = Moderate worsening (34-66% worsening); -1 = Slight worsening (1-33% worsening); 1= Slight improvement (1-33% improvement); 2 = Moderate improvement (34-66% improvement); 3 = Marked improvement (67-99% improvement); 4 = Complete clearance (100% improvement) |
| Secondary | Response Based on Clinical Global Assessment of Change CGA-C Score at 6 Weeks | 6 weeks | Clinical Global Assessment of Change (CGA-C) responder rate was the responder rate at 6 weeks based on the CGA-C score in bullous pemphigoid (BP). A patient with a CGA-C score of 3 or 4 indicating marked improvement from baseline at 6 weeks was considered a responder. The CGA-C is an investigator assessment of change from baseline and is scored as follows: -4 = Very marked worsening (100% worsening); -3 = Marked worsening (67-99% worsening); -2 = Moderate worsening (34-66% worsening); -1 = Slight worsening (1-33% worsening); 1= Slight improvement (1-33% improvement); 2 = Moderate improvement (34-66% improvement); 3 = Marked improvement (67-99% improvement); 4 = Complete clearance (100% improvement) |
| Secondary | Number of Patients Investigator Global Assessment Score Over 12 Weeks | Baseline (week 0), week 6 and week 12 | Investigator's Global Assessment (IGA) - (scale of 0 to 4, where 0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients That Had a Clinical Global Assessment of Change (CGA-C) Responder Rate by Week 12 | 12 weeks | Pharmacodynamics (PD) analysis set included all randomized patients. | number of participants | NUMBER |
| SECONDARY | Response Based on Clinical Global Assessment of Change CGA-C Score at 6 Weeks | 6 weeks | Pharmacodynamics (PD) analysis set included all randomized patients. | number of participants | NUMBER |
| SECONDARY | Number of Patients Investigator Global Assessment Score Over 12 Weeks | Baseline (week 0), week 6 and week 12 | Pharmacodynamics (PD) analysis set included all randomized patients. | Number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients That Had a Clinical Global Assessment of Change (CGA-C) Responder Rate by Week 12 | QGE031 | 8 | number of participants | ||
| Number of Patients That Had a Clinical Global Assessment of Change (CGA-C) Responder Rate by Week 12 | Placebo | 2 | number of participants | ||
| Response Based on Clinical Global Assessment of Change CGA-C Score at 6 Weeks | QGE031 | 8 | number of participants | ||
| Response Based on Clinical Global Assessment of Change CGA-C Score at 6 Weeks | Placebo | 2 | number of participants | ||
| Number of Patients Investigator Global Assessment Score Over 12 Weeks | QGE031 | Week 0 - IGA Score: 0 | 0 | Number of participants | |
| Number of Patients Investigator Global Assessment Score Over 12 Weeks | Placebo | Week 0 - IGA Score: 0 | 0 | Number of participants | |
| Number of Patients Investigator Global Assessment Score Over 12 Weeks | QGE031 | Week 6 - IGA Score: 0 | 1 | Number of participants | |
| Number of Patients Investigator Global Assessment Score Over 12 Weeks | Placebo | Week 6 - IGA Score: 0 | 2 | Number of participants | |
| Number of Patients Investigator Global Assessment Score Over 12 Weeks | QGE031 | Week 12 - IGA Score: 0 | 1 | Number of participants | |
| Number of Patients Investigator Global Assessment Score Over 12 Weeks | Placebo | Week 12 - IGA Score: 0 | 2 | Number of participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QGE031 | 13 | |
| Overall Study | STARTED | Placebo | 7 | |
| Overall Study | Safety Follow-up | QGE031 | 11 | |
| Overall Study | Safety Follow-up | Placebo | 5 | |
| Overall Study | COMPLETED | QGE031 | 10 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | QGE031 | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events582
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 | Anaemia | Blood and lymphatic system disorders | QGE031 | 1 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Open Label QGE031 | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Follow-up Period: QGE031 | 0 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Follow-up Period: Placebo | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Follow-up Period: Open Label QGE031 | 0 | 4 | |
| other | Lymphopenia | Blood and lymphatic system disorders | QGE031 | 0 | 13 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo | 1 | 7 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Open Label QGE031 | 0 | 4 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Follow-up Period: QGE031 | 0 | 11 |
1 to 10 of 582Source ClinicalTrials.gov
See all 582 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QGE031 | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Open Label QGE031 | ||
| Total, all-cause mortality | Follow-up Period: QGE031 | ||
| Total, all-cause mortality | Follow-up Period: Placebo | ||
| Total, all-cause mortality | Follow-up Period: Open Label QGE031 | ||
| Total, other adverse events | QGE031 | 11 | 13 |
| Total, other adverse events | Placebo | 6 | 7 |
| Total, other adverse events | Open Label QGE031 | 2 | 4 |
| Total, other adverse events | Follow-up Period: QGE031 | 10 | 11 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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/NCT01688882
GET https://conductscience.org/api/trials/v1/NCT01688882/results?page=2