Trial · NCT03762265
A Study of PRN1008 in Patients With Pemphigus
NCT03762265, Phase 3, Terminated, Principia Biopharma, a Sanofi Company; results first posted 2022-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of PRN1008 in Patients With Pemphigus. Trials, record NCT03762265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03762265
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of PRN1008 in Patients With Pemphigus
- NCT number
- NCT03762265
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 131 participants, actual
- Lead sponsor
- Principia Biopharma, a Sanofi Company
- Conditions
- Pemphigus
- Interventions
- Rilzabrutinib, Placebo
- First posted
- 2018-12-03
- Last updated
- 2023-08-02
- Other registries' IDs
- eudract:2018-002261-19
- Results first posted
- 2022-09-21
- Limitations and caveats
- Study was terminated prematurely by the Sponsor.
Source ClinicalTrials.gov
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Complete Remission (CR) With a Corticosteroids Dose of Less Than or Equal to (<=) 10 mg/Day From Week 29 to Week 37: Pemphigus Vulgaris Participants in Modified Intent-to-Treat (PV mITT) Population | From Week 29 to Week 37 | Complete remission was defined as absence of new and established lesions and was intended to mean "no disease activity" for 2 consecutive weeks, with Pemphigus Disease Area Index (PDAI) activity score =0 and CS dose \<=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this outcome measure (OM), percentage of participants who achieved CR while on a daily corticosteroids dose of \<=10 mg/day were reported. |
| Primary | Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=10 mg/Day From Week 29 to Week 37: Modified Intent-to-Treat (mITT) Population | From Week 29 to Week 37 | Complete remission was defined as absence of new and established lesions and was intended to mean "no disease activity" for 2 consecutive weeks, with PDAI activity score =0 and CS dose \<=10 mg. PDAI score weighted for number and size of lesions with score of 0 (absent) to 10 given for skin (12 body locations), scalp and mucous membrane showing disease activity (erosions/blisters or new erythema). PDAI total score ranged from 0 to 250 points representing disease activity (120 points for skin activity; 10 points for scalp activity; 120 points for mucosal activity). Higher score indicated more disease activity. In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of \<=10 mg/day were reported. |
| Secondary | Cumulative Oral Corticosteroid Dose From Baseline to Week 37: PV mITT Population | Baseline to Week 37 | The cumulative dose (in milligrams) of sponsor-provided oral CS (prednisone or prednisolone) received by the participants during the BT period was calculated from Baseline to Week 37 and is reported in this OM. |
| Secondary | Cumulative Oral Corticosteroid Dose From Baseline to Week 37: mITT Population | Baseline to Week 37 | The cumulative dose (in milligrams) of sponsor-provided oral CS (prednisone or prednisolone) received by the participants during the BT period was calculated from Baseline to Week 37 and is reported in this OM. |
| Secondary | Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: PV mITT Population | Baseline to Week 37 | Cumulative duration (in days) of CR post first CS dose of \<= 10 mg/day from Baseline to Week 37 was analyzed with a zero-inflated negative binomial model with terms of treatment group and disease history, and an offset based on the number of days on blinded treatment period and were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity". |
| Secondary | Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: mITT Population | Baseline to Week 37 | Cumulative duration (in days) of CR post first CS dose of \<= 10 mg/day from Baseline to Week 37 was analyzed with a zero-inflated negative binomial model with terms of treatment group and disease history, and an offset based on the number of days on blinded treatment period and were reported in this OM. Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity". |
| Secondary | Time to First Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: PV mITT Population | Baseline to Week 37 | Time to first CR was the time (in days) to achieve CR while on CS dose of \<=10 mg/day. Complete remission was defined as the absence of new and established lesions to the "no disease activity". Kaplan-Meier method was used for the analysis. |
| Secondary | Time to First Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: mITT Population | Baseline to Week 37 | Time to first CR was the time (in days) to achieve CR while on CS dose of \<=10 mg/day. Complete remission was defined as the absence of new and established lesions to the "no disease activity". Kaplan-Meier method was used for the analysis. |
| Secondary | Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=5 mg/Day From Week 29 to Week 37: PV mITT Population | From Week 29 to Week 37 | Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity". In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of \<=5 mg/day were reported. |
| Secondary | Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=5 mg/Day From Week 29 to Week 37: mITT Population | From Week 29 to Week 37 | Complete remission was defined as the absence of new and established lesions and was intended to mean "no disease activity". In this OM, percentage of participants who achieved CR while on a daily corticosteroids dose of \<=5 mg/day were reported. |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 registered outcomesOutcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Complete Remission (CR) With a Corticosteroids Dose of Less Than or Equal to (<=) 10 mg/Day From Week 29 to Week 37: Pemphigus Vulgaris Participants in Modified Intent-to-Treat (PV mITT) Population | From Week 29 to Week 37 | Analysis was performed on PV mITT which included randomized PV participants who had received at least one dose of study medication and were analyzed according to the treatment they were allocated to at randomization. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=10 mg/Day From Week 29 to Week 37: Modified Intent-to-Treat (mITT) Population | From Week 29 to Week 37 | Analysis was performed on mITT population which included all randomized participants (i.e. PV + PF participants) who had received at least one dose of study medication and were analyzed according to the treatment they were allocated to at randomization. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Oral Corticosteroid Dose From Baseline to Week 37: PV mITT Population | Baseline to Week 37 | Analysis was performed on PV mITT population. | milligrams | MEAN |
| SECONDARY | Cumulative Oral Corticosteroid Dose From Baseline to Week 37: mITT Population | Baseline to Week 37 | Analysis was performed on mITT population. | milligrams | MEAN |
| SECONDARY | Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: PV mITT Population | Baseline to Week 37 | Analysis was performed on PV mITT population. | days | MEAN |
| SECONDARY | Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: mITT Population | Baseline to Week 37 | Analysis was performed on mITT population. | days | MEAN |
| SECONDARY | Time to First Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: PV mITT Population | Baseline to Week 37 | Analysis was performed on PV mITT population. | days | MEDIAN |
| SECONDARY | Time to First Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: mITT Population | Baseline to Week 37 | Analysis was performed on mITT population. | days | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=5 mg/Day From Week 29 to Week 37: PV mITT Population | From Week 29 to Week 37 | Analysis was performed on PV mITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=5 mg/Day From Week 29 to Week 37: mITT Population | From Week 29 to Week 37 | Analysis was performed on mITT population. | percentage of participants | NUMBER |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group238
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants Who Achieved Complete Remission (CR) With a Corticosteroids Dose of Less Than or Equal to (<=) 10 mg/Day From Week 29 to Week 37: Pemphigus Vulgaris Participants in Modified Intent-to-Treat (PV mITT) Population | Placebo Then Rilzabrutinib | 18.2 | percentage of participants | ||
Percentage of Participants Who Achieved Complete Remission (CR) With a Corticosteroids Dose of Less Than or Equal to (<=) 10 mg/Day From Week 29 to Week 37: Pemphigus Vulgaris Participants in Modified Intent-to-Treat (PV mITT) Population | Rilzabrutinib Then Rilzabrutinib | 24.1 | percentage of participants | ||
| Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=10 mg/Day From Week 29 to Week 37: Modified Intent-to-Treat (mITT) Population | Placebo Then Rilzabrutinib | 18.2 | percentage of participants | ||
| Percentage of Participants Who Achieved Complete Remission With a Corticosteroids Dose of <=10 mg/Day From Week 29 to Week 37: Modified Intent-to-Treat (mITT) Population | Rilzabrutinib Then Rilzabrutinib | 26.2 | percentage of participants | ||
| Cumulative Oral Corticosteroid Dose From Baseline to Week 37: PV mITT Population | Placebo Then Rilzabrutinib | 5653.2 | Standard Deviation 3155.97 | milligrams | |
| Cumulative Oral Corticosteroid Dose From Baseline to Week 37: PV mITT Population | Rilzabrutinib Then Rilzabrutinib | 5131.4 | Standard Deviation 2623.92 | milligrams | |
| Cumulative Oral Corticosteroid Dose From Baseline to Week 37: mITT Population | Placebo Then Rilzabrutinib | 5392.2 | Standard Deviation 2993.02 | milligrams | |
| Cumulative Oral Corticosteroid Dose From Baseline to Week 37: mITT Population | Rilzabrutinib Then Rilzabrutinib | 4860.2 | Standard Deviation 2545.32 | milligrams | |
| Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: PV mITT Population | Placebo Then Rilzabrutinib | 34.1 | Standard Deviation 51.58 | days | |
| Cumulative Duration of Complete Remission With a Corticosteroids Dose <=10 mg/Day From Baseline to Week 37: PV mITT Population | Rilzabrutinib Then Rilzabrutinib | 50.5 | Standard Deviation 67.10 | days |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| BT Period: Weeks 1 to 37 | STARTED | Placebo Then Rilzabrutinib | 66 | |
| BT Period: Weeks 1 to 37 | STARTED | Rilzabrutinib Then Rilzabrutinib | 65 | |
| BT Period: Weeks 1 to 37 | COMPLETED | Placebo Then Rilzabrutinib | 51 | |
| BT Period: Weeks 1 to 37 | COMPLETED | Rilzabrutinib Then Rilzabrutinib | 62 | |
| BT Period: Weeks 1 to 37 | NOT COMPLETED | Placebo Then Rilzabrutinib | 15 | |
| BT Period: Weeks 1 to 37 | NOT COMPLETED | Rilzabrutinib Then Rilzabrutinib | 3 | |
| OLE Period: Weeks 37 to 61 | STARTED | Placebo Then Rilzabrutinib | 51 | |
| OLE Period: Weeks 37 to 61 | STARTED | Rilzabrutinib Then Rilzabrutinib | 61 | |
| OLE Period: Weeks 37 to 61 | COMPLETED | Placebo Then Rilzabrutinib | 35 | |
| OLE Period: Weeks 37 to 61 | COMPLETED | Rilzabrutinib Then Rilzabrutinib | 45 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events424
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 | Herpes Simplex | Infections and infestations | BT Period: Placebo | 0 | 66 | 0 |
| other | Herpes Simplex | Infections and infestations | BT Period: Rilzabrutinib | 1 | 65 | 1 |
| other | Herpes Simplex | Infections and infestations | OLE Period: Placebo Then Rilzabrutinib | 0 | 51 | 0 |
| other | Herpes Simplex | Infections and infestations | OLE Period: Rilzabrutinib Then Rilzabrutinib | 0 | 61 | 0 |
| other | Herpes Simplex | Infections and infestations | OLE Period: Overall (All Participants) | 0 | 112 | 0 |
| other | Herpes Simplex | Infections and infestations | LTE Period: Placebo Then Rilzabrutinib | 0 | 35 | 0 |
| other | Herpes Simplex | Infections and infestations | LTE Period: Rilzabrutinib Then Rilzabrutinib | 2 | 34 | 4 |
| other | Herpes Simplex | Infections and infestations | LTE Period: Overall (All Participants) | 2 | 69 | 4 |
| other | Oral Herpes | Infections and infestations | BT Period: Placebo | 1 | 66 | 1 |
| other | Oral Herpes | Infections and infestations | BT Period: Rilzabrutinib | 3 | 65 | 3 |
1 to 10 of 424Source ClinicalTrials.gov
See all 424 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BT Period: Placebo | 2 | 66 |
| Total, all-cause mortality | BT Period: Rilzabrutinib | 0 | 65 |
| Total, all-cause mortality | OLE Period: Placebo Then Rilzabrutinib | 0 | 51 |
| Total, all-cause mortality | OLE Period: Rilzabrutinib Then Rilzabrutinib | 0 | 61 |
| Total, all-cause mortality | OLE Period: Overall (All Participants) | 0 | 112 |
| Total, all-cause mortality | LTE Period: Placebo Then Rilzabrutinib | 0 | 35 |
| Total, all-cause mortality | LTE Period: Rilzabrutinib Then Rilzabrutinib | 0 | 34 |
| Total, all-cause mortality | LTE Period: Overall (All Participants) | 0 | 69 |
| Total, other adverse events | BT Period: Placebo | 41 | 66 |
| Total, other adverse events | BT Period: Rilzabrutinib | 47 | 65 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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/NCT03762265
GET https://conductscience.org/api/trials/v1/NCT03762265/registered?page=2