Trial · NCT02704429
A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris
NCT02704429, Phase 2, Completed, Principia Biopharma, a Sanofi Company; results first posted 2023-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris. Trials, record NCT02704429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02704429
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris
- NCT number
- NCT02704429
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Principia Biopharma, a Sanofi Company
- Conditions
- Pemphigus Vulgaris
- Interventions
- PRN1008
- First posted
- 2016-03-10
- Last updated
- 2023-02-13
- Other registries' IDs
- eudract:2015-003564-37
- Results first posted
- 2023-02-13
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-emergent Adverse Events | Part A: until 24 weeks and Part B: until 28 weeks | Treatment-emergent adverse events (TEAEs) including clinically significant changes in physical examination, laboratory tests, and vital signs. An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment phase that was defined as the time from the start of study drug up to study completion. |
| Primary | Percentage of Participants Who Are Able to Achieve Control of Disease Activity (CDA) Within 4 Weeks of Starting PRN1008 Treatment Without the Need for Doses of Prednisone or Prednisolone >0.5 mg/kg | 4 weeks | CDA was defined as the time at which new lesions cease to form and established lesions begin to heal. |
| Secondary | Percentage of Participants Able to Achieve Control of Disease Activity (CDA) Without Corticosteroids Within 4 Weeks | 4 weeks | CDA was defined as the time at which new lesions cease to form and established lesions begin to heal. |
| Secondary | Percentage of Participants Able to Achieve a Complete Response (CR) Without Corticosteroids | Part A: 12 weeks treatment and Part B: 24 weeks treatment | CR was defined as complete healing of all lesions and the absence of new lesions. |
| Secondary | Percentage of Participants Able to Achieve Complete Remission (CR) Without the Need for Doses of Prednisone or Prednisolone of Greater Than 0.5mg/kg | Part A: 12 weeks treatment and Part B: 24 weeks treatment | CR was defined as complete healing of all lesions and the absence of new lesions. |
| Secondary | Time to Control of Disease Activity (CDA) | Part A: until 24 weeks and Part B: until 28 weeks | CDA was defined as the time at which new lesions cease to form and established lesions begin to heal. Kaplan-Meier estimate median time is reported. |
| Secondary | Time to End of Consolidation Phase (ECP) | Part A: until 24 weeks and Part B: until 28 weeks | ECP was defined as the time at which no new lesions have developed for minimum of 2 weeks, and approximately 80% of existing lesions have healed. The median time to ECP was based on Kaplan-Meier estimate which considered censoring at end of follow-up for patients who didn't have an event. A +/-3 days window for visits at Week 3 and 5, and +/-7 days window for visits at Week 9, 13, 17, 21, 25. |
| Secondary | Time to Complete Remission (CR) | Part A: until 24 weeks and Part B: until 28 weeks | CR was defined as complete healing of all lesions and the absence of new lesions. |
| Secondary | Time to Relapse After PRN1008 Treatment Discontinuation | Part A: until 24 weeks and Part B: until 28 weeks | Relapse was defined as appearance of ≥3 new lesions/month that do not heal spontaneously within 1 week, or by extension of established lesions, in a patient who has achieved disease control. The median time to relapse was based on Kaplan-Meier estimate which considered censoring at end of follow-up for patients who didn't have an event. A +/-3 days window for visits at Week 3 and 5, and +/-7 days window for visits at Week 9, 13, 17, 21, 25. |
| Secondary | Cumulative Corticosteroid Usage | Part A: until 24 weeks and Part B: until 28 weeks | Cumulative corticosteroid usage |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-emergent Adverse Events | Part A: until 24 weeks and Part B: until 28 weeks | Safety Analysis population: All patients who received at least 1 dose of rilzabrutinib; used for all safety analyses | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Are Able to Achieve Control of Disease Activity (CDA) Within 4 Weeks of Starting PRN1008 Treatment Without the Need for Doses of Prednisone or Prednisolone >0.5 mg/kg | 4 weeks | Intent-to-Treat (ITT) population: All patients who received at least 1 dose of rilzabrutinib | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Able to Achieve Control of Disease Activity (CDA) Without Corticosteroids Within 4 Weeks | 4 weeks | ITT | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Able to Achieve a Complete Response (CR) Without Corticosteroids | Part A: 12 weeks treatment and Part B: 24 weeks treatment | ITT | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Able to Achieve Complete Remission (CR) Without the Need for Doses of Prednisone or Prednisolone of Greater Than 0.5mg/kg | Part A: 12 weeks treatment and Part B: 24 weeks treatment | ITT | percentage of participants | NUMBER |
| SECONDARY | Time to Control of Disease Activity (CDA) | Part A: until 24 weeks and Part B: until 28 weeks | ITT | days | MEDIAN |
| SECONDARY | Time to End of Consolidation Phase (ECP) | Part A: until 24 weeks and Part B: until 28 weeks | ITT | days | MEDIAN |
| SECONDARY | Time to Complete Remission (CR) | Part A: until 24 weeks and Part B: until 28 weeks | ITT | days | MEDIAN |
| SECONDARY | Time to Relapse After PRN1008 Treatment Discontinuation | Part A: until 24 weeks and Part B: until 28 weeks | ITT | days | MEDIAN |
| SECONDARY | Cumulative Corticosteroid Usage | Part A: until 24 weeks and Part B: until 28 weeks | ITT | mg | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events | Part A | Any TEAE | 74.1 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events | Part B | Any TEAE | 86.7 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events | Part A | Any serious TEAE | 11.1 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events | Part B | Any serious TEAE | 0 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events | Part A | Any TEAE leading to treatment discontinuation | 11.1 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events | Part B | Any TEAE leading to treatment discontinuation | 0 | percentage of participants | |
| Percentage of Participants Who Are Able to Achieve Control of Disease Activity (CDA) Within 4 Weeks of Starting PRN1008 Treatment Without the Need for Doses of Prednisone or Prednisolone >0.5 mg/kg | Part A | 51.9 | 95% Confidence Interval 31.9 to 71.3 | percentage of participants | |
| Percentage of Participants Who Are Able to Achieve Control of Disease Activity (CDA) Within 4 Weeks of Starting PRN1008 Treatment Without the Need for Doses of Prednisone or Prednisolone >0.5 mg/kg | Part B | 60.0 | 95% Confidence Interval 32.29 to 83.66 | percentage of participants | |
| Percentage of Participants Able to Achieve Control of Disease Activity (CDA) Without Corticosteroids Within 4 Weeks | Part A | 11.1 | 95% Confidence Interval 2.4 to 29.2 | percentage of participants | |
| Percentage of Participants Able to Achieve Control of Disease Activity (CDA) Without Corticosteroids Within 4 Weeks | Part B | 6.7 | 95% Confidence Interval 0.17 to 31.95 | percentage of participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A: 24 Weeks | STARTED | Part A | 27 | |
| Part A: 24 Weeks | STARTED | Part B | 0 | |
| Part A: 24 Weeks | COMPLETED | Part A | 24 | |
| Part A: 24 Weeks | COMPLETED | Part B | 0 | |
| Part A: 24 Weeks | NOT COMPLETED | Part A | 3 | |
| Part A: 24 Weeks | NOT COMPLETED | Part B | 0 | |
| Part B: 28 Weeks | STARTED | Part A | 0 | |
| Part B: 28 Weeks | STARTED | Part B | 15 | |
| Part B: 28 Weeks | COMPLETED | Part A | 0 | |
| Part B: 28 Weeks | COMPLETED | Part B | 14 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events140
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 | Nausea | Gastrointestinal disorders | Part A | 6 | 27 | |
| other | Nausea | Gastrointestinal disorders | Part B | 4 | 15 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part A | 3 | 27 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part B | 1 | 15 | |
| other | Diarrhoea | Gastrointestinal disorders | Part A | 3 | 27 | |
| other | Diarrhoea | Gastrointestinal disorders | Part B | 0 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Part A | 2 | 27 | |
| other | Abdominal pain | Gastrointestinal disorders | Part B | 0 | 15 | |
| other | Dry mouth | Gastrointestinal disorders | Part A | 2 | 27 | |
| other | Dry mouth | Gastrointestinal disorders | Part B | 0 | 15 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A | 0 | 27 |
| Total, all-cause mortality | Part B | 0 | 15 |
| Total, other adverse events | Part A | 20 | 27 |
| Total, other adverse events | Part B | 13 | 15 |
| Total, serious adverse events | Part A | 3 | 27 |
| Total, serious adverse events | Part B | 0 | 15 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part A vs Part B: deaths from any cause | Trial comparisons |
| Part A vs Part B: serious adverse events | Trial comparisons |
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/NCT02704429
GET https://conductscience.org/api/trials/v1/NCT02704429/results?page=2