Trial · NCT02736409
Outcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants Who Had Relapse During the Entire Week 36 Period | Week 36 | SHP621-301 (NCT02605837) BOS Full Responder FAS consisted of all randomized participants who were determined to be Full responders to the BOS treatment during the induction study SHP621-301 (NCT02605837) and who received at least 1 dose of IP in the SHP621-302 (NCT02736409) study. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Long-term Treatment Response From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 36 of Current Study | Week 36 | SHP621-301 (NCT02605837) BOS Non responder FAS included all randomized participants who did not respond or partially responded to assigned BOS treatment in the induction study SHP621-301 (NCT02605837) and who received at least 1 dose of IP in the SHP621-302 (NCT02736409) study. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Long-term Treatment Response From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 36 | Week 36 | SHP621-301 (NCT02605837) BOS Non responder FAS included all randomized participants who did not respond or partially responded to assigned BOS treatment in the induction study SHP621-301 (NCT02605837) and who received at least 1 dose of IP in the SHP621-302 (NCT02736409) study. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants Who Had a Histologic Response (Eosinophil Count of Less Than or Equal to (<or=6)/High-Powered Field [HPF]) at Week 12 and Week 36 | Week 12 and Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants Who Had at Least a 30 Percent (%) Change in DSQ Combined Score From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 12 and Week 36 | Baseline of SHP621-301 (NCT02605837), Week 12 and Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants Who Had at Least a 30 Percent (%) Change in DSQ Combined Score From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 12 and Week 36 | Baseline of Current Study (SHP621-302 [NCT02736409]), Week 12 and Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. | proportion of participants | NUMBER |
| SECONDARY | Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Total Endoscopy Score at Week 12 and Week 36 of Current Study | Baseline of induction study (SHP621-301 [NCT02605837]), Week 12 and Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who had an evaluable Induction Study (SHP621-301 \[NCT02605837\]) baseline and assessment at specific category/time point. | Score on scale | MEAN |
| SECONDARY | Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Total Endoscopy Score at Week 12 and Week 36 | Baseline of Current Study (SHP621-302 [NCT02736409]), Week 12 and Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who had an evaluable current Study (SHP621-302 \[NCT02736409\]) baseline and assessment at specific category/time point. | Score on scale | MEAN |
| SECONDARY | Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Peak Eosinophil Count at Week 12 and Week 36 of Current Study | Baseline of induction study (SHP621-301 [NCT02605837]), Week 12 and Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who had an evaluable Induction Study (SHP621-301 \[NCT02605837\]) baseline and assessment at specific category/time point. | eosinophil count | MEAN |
| SECONDARY | Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Peak Eosinophil Count at Week 12 and Week 36 | Baseline of Current Study (SHP621-302 [NCT02736409]), Week 12 and Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who had an evaluable current Study (SHP621-302 \[NCT02736409\]) baseline and assessment at specific category/time point. | eosinophil count | MEAN |
| SECONDARY | Proportion of Participants Who Had Peak Eosinophil Count Less Than (<) 15/High-Powered Field (HPF) at Week 12 and Week 36 | Week 12 and Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure at specific category. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants Who Had Peak Eosinophil Count Less Than or Equal to (< or =) 1/High-Powered Field (HPF) at Week 12 and Week 36 | Week 12 and Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. | proportion of participants | NUMBER |
| SECONDARY | Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 of Current Study | Baseline of induction study (SHP621-301 [NCT02605837]), Week 12 and Week 36 | FAS included all randomized participants who received at least one dose of a SHP621-302 (NCT02736409) investigational product. Here the number of participants analyzed signifies participants who had an evaluable Induction Study (SHP621-301 \[NCT02605837\]) baseline and assessment at specific category/time point. | eosinophil count | MEAN |
| SECONDARY | Change From Current Study (SHP621-302 [NCT02736409]) Baseline in Peak Eosinophil Count for Each Available Esophageal Level (Proximal, Mid, and Distal) at Week 12 and Week 36 | Baseline of Current Study (SHP621-302 [NCT02736409]), Week 12 and Week 36 | FAS included all randomized participants who received at least one dose of a SHP621-302 (NCT02736409) investigational product. Here the number of participants analyzed signifies participants who had an evaluable current Study (SHP621-302 \[NCT02736409\]) baseline and assessment at specific category/time point. | eosinophil count | MEAN |
| SECONDARY | Change From Induction Study (SHP621-301 [NCT02605837]) Baseline in the Histopathologic Epithelial Features Combined Total Score (Grade and Stage) at Week 12 an Week 36 of Current Study | Baseline of induction study (SHP621-301 [NCT02605837]), Week 12 and Week 36 | FAS included all randomized participants who received at least one dose of a SHP621-302 (NCT02736409) investigational product. Here the number of participants analyzed signifies participants who had an evaluable Induction Study (SHP621-301 \[NCT02605837\]) baseline and assessment at specific category/time point. | score on scale | MEAN |
| SECONDARY | Change From Current Study (SHP621-302 [NCT02736409]) Baseline in the Histopathologic Epithelial Features Combined Total Score (Grade and Stage) at Week 12 and Week 36 | Baseline of Current Study (SHP621-302 [NCT02736409]), Week 12 and Week 36 | FAS included all randomized participants who received at least one dose of a SHP621-302 (NCT02736409) investigational product. Here the number of participants analyzed signifies participants who had an evaluable current Study (SHP621-302 \[NCT02736409\]) baseline and assessment at specific category/time point. | score on scale | MEAN |
| SECONDARY | Proportion of Participants Who Had Greater Than or Equal to (>or=) 50 Percent (%) Reduction in DSQ Combined Score From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 12 and Week 36 | Week 12 and Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants Who Had Greater Than or Equal to (>or=) 50 Percent (%) Reduction in DSQ Combined Score From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 12 and Week 36 | Week 12 and Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. | proportion of participants | NUMBER |
| SECONDARY | Change in the DSQ Combined Score (Questions 2+3) From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 36 of Current Study | Baseline of induction study (SHP621-301 [NCT02605837]), Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | score on scale | MEAN |
| SECONDARY | Change in the DSQ Combined Score (Questions 2+3) From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 36 | Baseline of Current Study (SHP621-302 [NCT02736409]), Week 36 | FAS consisted of all randomized participants who received at least 1 dose of investigational product in the SHP621-302 (NCT02736409) study. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | score on scale | 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.
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