Trial · NCT04424927
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24 | Baseline (average of Day -7 to Day -1) up to Week 24 | The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and up to Week 24 are reported. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24 | Baseline (average of Day -7 to Day -1) up to Week 24 | The mITT analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and up to Week 24 are reported. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through Week 24 | Baseline (average of Day -7 to Day -1) up to Week 24 | The mITT analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and up to Week 24 are reported. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Intraepithelial Lymphocyte (IEL) Density at Week 24 | Baseline to Week 24 | The mITT analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and Week 24 are reported. | cells/100 epithelial cells | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs) | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days | The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Important Changes in Hematology | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days | The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Only participants with data collected are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days | The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Only participants with data collected are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Important Changes in Urinalysis | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days | The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Only participants with data collected for each specific parameter are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight | From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days | The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Anti-PRV-015 Antibodies | Baseline (Day 1) and Weeks 2, 4, 12, 22, 24 and 28 | The Immunogenicity analysis set included participants who were randomized, dosed, and had at least 1 evaluable immunogenicity assessment. Only participants with data collected at specific time point are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Minimum Serum Concentrations (Cmin) of PRV-015 | Pre-dose on Day 1 and Weeks 2, 4, 8, 12, 16, 20, 22, 24 and 28 | The Pharmacokinetic (PK) analysis set included participants who were randomized, dosed, and had at least 1 post-dose evaluable PK assessment. Only participants with data collected at specific time point are reported. Participants were not analyzed at pre-dose on Day 1 as the study drug was not administered. Hence, no data collected. | nanogram per milliliter | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT04424927/outcomes