Trial · NCT03701555
A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease
NCT03701555, Phase 1, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2023-04-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease. Trials, record NCT03701555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03701555
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of PVP001, PVP002, and PVP003 in Healthy Adults and PVP001 and PVP002 in Adults With Celiac Disease
- NCT number
- NCT03701555
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 139 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Digestive System Disease
- Interventions
PvP001 placebo, PvP001 100 mg, PvP001 300 mg, PvP001 900 mg, Maximum Feasible Dose (MFD) of PvP002, Maximum Tolerated Dose (MTD) of PvP001, MTD of PvP001 following 7 days of PPI treatment, PvP002 placebo, PvP001 600 mg, PvP003 placebo, PvP003, PvP003 150 mg
- First posted
- 2018-10-10
- Last updated
- 2023-04-04
- Results first posted
- 2023-04-04
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) | |
| Primary | Part 4: Number of Participants Reporting One or More TEAEs for PvP003 After Multiple Doses | Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28) | |
| Primary | Part 1: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Events (TESAEs) for PvP001 and PvP002 | Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) | |
| Primary | Part 4: Number of Participants Reporting One or More TESAEs for PvP003 600 mg After Multiple Doses | Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28) | |
| Primary | Part 2, Group 1, Cohort 2B: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 Gram (gm) Gluten-containing Study Meal After Administration of PvP001 | Cohort Treatment Day | Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using Enzyme-Linked Immunosorbent Assay (ELISA) based on the monoclonal R5 and G12 antibodies. |
| Primary | Part 2, Group 2, Cohort 2E: Median Percentage of Gluten Degradation by PvP002 in a Standardized 3 gm Gluten-containing Study Meal After Administration of PvP002 | Cohort Treatment Day | Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
| Primary | Part 2, Group 1, Cohort 2C: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 gm Gluten-containing Study Meal Following 7 Days of Standard Dose PPI Treatment | Cohort Treatment Day | Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
| Primary | Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 20 Minutes After Administration of PvP001 | Cohort Treatment Day: at 20 minutes post-dose | Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
| Primary | Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP001 | Cohort Treatment Day: at 35 minutes post-dose | Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
| Primary | Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP001 | Cohort Treatment Day: at 65 minutes post-dose | Median percentage degraded relative to placebo was derived using the formula: (1 - \[active/placebo\])\*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) | Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 4: Number of Participants Reporting One or More TEAEs for PvP003 After Multiple Doses | Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28) | Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 4 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Events (TESAEs) for PvP001 and PvP002 | Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) | Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 1 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 4: Number of Participants Reporting One or More TESAEs for PvP003 600 mg After Multiple Doses | Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28) | Safety population included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed only for Part 4 of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2, Group 1, Cohort 2B: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 Gram (gm) Gluten-containing Study Meal After Administration of PvP001 | Cohort Treatment Day | Intent-to-Treat (ITT) population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 1, Cohort 2B (PvP001 900 mg) of Part 2 only. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure. | percentage of gluten degradation | MEDIAN |
| PRIMARY | Part 2, Group 2, Cohort 2E: Median Percentage of Gluten Degradation by PvP002 in a Standardized 3 gm Gluten-containing Study Meal After Administration of PvP002 | Cohort Treatment Day | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 2, Cohort 2E (PvP002 600 mg) of Part 2 only. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure. | percentage of gluten degradation | MEDIAN |
| PRIMARY | Part 2, Group 1, Cohort 2C: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 gm Gluten-containing Study Meal Following 7 Days of Standard Dose PPI Treatment | Cohort Treatment Day | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 1, Cohort 2C (PvP001 900 mg) of Part 2 only. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure. | percentage of gluten degradation | MEDIAN |
| PRIMARY | Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 20 Minutes After Administration of PvP001 | Cohort Treatment Day: at 20 minutes post-dose | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2G (PvP001 300 mg) and Cohort 2H (PvP001 600 mg) of Part 2 only. | percentage of gluten degradation | MEDIAN |
| PRIMARY | Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP001 | Cohort Treatment Day: at 35 minutes post-dose | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2G (PvP001 300 mg) and Cohort 2H (PvP001 600 mg) of Part 2 only. | percentage of gluten degradation | MEDIAN |
| PRIMARY | Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP001 | Cohort Treatment Day: at 65 minutes post-dose | ITT population in Part 2 of the study, included all participants who received at least one dose of study drug. As planned, this outcome measure was assessed in Group 3, Cohort 2G (PvP001 300 mg) and Cohort 2H (PvP001 600 mg) of Part 2 only. | percentage of gluten degradation | MEDIAN |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group171
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | Part 1, (1A-1): PvP001 Placebo | 0 | Participants | ||
| Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | Part 1, (1B-1): PvP001 100 mg | 0 | Participants | ||
| Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | Part 1, (1C-1): PvP001 300 mg | 0 | Participants | ||
| Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | Part 1, (1D-1): PvP001 900 mg | 0 | Participants | ||
| Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | Part 1, (1E-1): PvP002 600 mg | 0 | Participants | ||
| Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | Part 1, (1A-2): PvP001 Placebo | 3 | Participants | ||
| Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | Part 1, (1B-2): PvP001 100 mg | 0 | Participants | ||
| Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | Part 1, (1C-2): PvP001 300 mg | 2 | Participants | ||
| Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | Part 1, (1D-2): PvP001 900 mg | 1 | Participants | ||
| Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 | Part 1, (1E-2): PvP002 600 mg | 1 | Participants |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 results by groupParticipant flow648
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 (Day 1) | STARTED | Part 1, (1A-1): PvP001 Placebo | 3 | |
| Part 1 (Day 1) | STARTED | Part 1, (1B-1): PvP001 100 mg | 3 | |
| Part 1 (Day 1) | STARTED | Part 1, (1C-1): PvP001 300 mg | 3 | |
| Part 1 (Day 1) | STARTED | Part 1, (1D-1): PvP001 900 mg | 3 | |
| Part 1 (Day 1) | STARTED | Part 1, (1E-1): PvP002 600 mg | 3 | |
| Part 1 (Day 1) | STARTED | Part 1, (1A-2): PvP001 Placebo | 3 | |
| Part 1 (Day 1) | STARTED | Part 1, (1B-2): PvP001 100 mg | 3 | |
| Part 1 (Day 1) | STARTED | Part 1, (1C-2): PvP001 300 mg | 3 | |
| Part 1 (Day 1) | STARTED | Part 1, (1D-2): PvP001 900 mg | 3 | |
| Part 1 (Day 1) | STARTED | Part 1, (1E-2): PvP002 600 mg | 1 |
1 to 10 of 648Source ClinicalTrials.gov
See all 648 participant flowAdverse events216
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 1, (1A-1): PvP001 Placebo | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | Part 1, (1B-1): PvP001 100 mg | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | Part 1, (1C-1): PvP001 300 mg | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | Part 1, (1D-1): PvP001 900 mg | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | Part 1, (1E-1): PvP002 600 mg | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | Part 1, (1A-2): PvP001 Placebo | 1 | 3 | |
| other | Nausea | Gastrointestinal disorders | Part 1, (1B-2): PvP001 100 mg | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | Part 1, (1C-2): PvP001 300 mg | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | Part 1, (1D-2): PvP001 900 mg | 1 | 3 | |
| other | Nausea | Gastrointestinal disorders | Part 1, (1E-2): PvP002 600 mg | 1 | 1 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals81
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1, (1A-1): PvP001 Placebo | 0 | 3 |
| Total, all-cause mortality | Part 1, (1B-1): PvP001 100 mg | 0 | 3 |
| Total, all-cause mortality | Part 1, (1C-1): PvP001 300 mg | 0 | 3 |
| Total, all-cause mortality | Part 1, (1D-1): PvP001 900 mg | 0 | 3 |
| Total, all-cause mortality | Part 1, (1E-1): PvP002 600 mg | 0 | 3 |
| Total, all-cause mortality | Part 1, (1A-2): PvP001 Placebo | 0 | 3 |
| Total, all-cause mortality | Part 1, (1B-2): PvP001 100 mg | 0 | 3 |
| Total, all-cause mortality | Part 1, (1C-2): PvP001 300 mg | 0 | 3 |
| Total, all-cause mortality | Part 1, (1D-2): PvP001 900 mg | 0 | 3 |
| Total, all-cause mortality | Part 1, (1E-2): PvP002 600 mg | 0 | 1 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33741317 | DERIVED |
Source PubMed
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 4: PvP003 600 mg, TID (4B) vs Part 4: PvP003 Placebo, TID (4A): Part 4: Number of Participants Reporting One or More TEAEs for PvP003 After Multiple Doses | Trial comparisons |
| Part 4: PvP003 600 mg, TID (4B) vs Part 4: PvP003 Placebo, TID (4A): Part 4: Number of Participants Reporting One or More TESAEs for PvP003 600 mg After Multiple Doses | 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/NCT03701555
GET https://conductscience.org/api/trials/v1/NCT03701555/registered?page=2