Trial · NCT02736409
An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)
NCT02736409, Phase 3, Completed, Shire; results first posted 2021-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE). Trials, record NCT02736409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02736409
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)
- NCT number
- NCT02736409
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 219 participants, actual
- Lead sponsor
- Shire
- Conditions
- Eosinophilic Esophagitis (EoE)
- Interventions
- Oral Budesonide Suspension (OBS), Placebo
- First posted
- 2016-04-13
- Last updated
- 2025-02-19
- Results first posted
- 2021-01-13
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Who Had Relapse During the Entire Week 36 Period | Week 36 | Relapse (Yes/No) was defined as meeting both the eosinophil histology relapse criterion and the dysphagia symptom relapse criterion. Eosinophil histology relapse was defined as an eosinophil count of greater than or equal to(\> or =) 15 per high-power field (eos/hpf) from at least 2 of 3 levels of the esophagus. Dysphagia symptom relapse was defined as having at least 4 days of dysphagia (with answer 'Yes' for question 2 in DSQ \[Dysphagia Symptom Questionnaire\]) in the 2-week period prior to the scheduled visit, as determined by the DSQ. |
| Secondary | Proportion of Participants With Long-term Treatment Response From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 36 of Current Study | Week 36 | Long-term response from SHP621-301 baseline defined: histologic response,defined as peak eosinophil count of less than or equal to(\< or =)6/HPF across all available esophageal levels at Week 36 and Dysphagia symptom response 1,defined as \>or= 30 percent(%) reduction in DSQ combined score(Questions \[Q\] 2+3) from baseline of SHP621-301 to Week 36.DSQcontain 4 questions,all participants used diary,responded to Q1(didyoueatsolid food),Q2(did food pass slowly or get stuck). If participant's answer to Q2 was No,diary ended for day. If participant answered Yes,he/she advanced to Q3(didyouhavetodoanything to make food go downorget relief), Q4(extent to which participant experienced pain while swallowing).DSQ combined score= (\[sum of points from Q2+3 in daily DSQ\]×14)/Number of diaries reported with non-missing data.Scale range was0-2 forQ2 and 0-4 forQ 3.Scale range for DSQ combined score was 0-84.Highervaluesrepresentingworseoutcome.Negative change from baseline indicates symptoms decreased. |
| Secondary | Proportion of Participants With Long-term Treatment Response From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 36 | Week 36 | Long-term response from baseline defined: histologic response, defined as peak eosinophil count of less than or equal to(\< or =) 6/HPF across all available esophageal levels at Week 36 and Dysphagia symptom response 1,defined as \>or= 30 percent(%) reduction in DSQ combined score (Questions \[Q\] 2+3) from baseline of SHP621-301 to Week 36.DSQcontain 4 questions,all participants used diary,responded to Q1(did you eat solid food),Q2(did food pass slowly or get stuck). If participant's answer to Q2 was No,diary ended for day. If participant answered Yes,he/she advanced to Q3(didyouhavetodoanything to make food go downorget relief), Q4(extent to which participant experienced pain while swallowing).DSQ combined score= (\[sum of points from Q2+3 in daily DSQ\]×14)/Number of diaries reported with non-missing data.Scale range was0-2 forQ2 and 0-4 forQ 3.Scale range for DSQ combined score was 0-84. Higher values representing worse outcome.Negative change from baseline indicates symptoms decreased. |
| 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 | Histology response was defined as a peak eosinophil count of \<or=6/HPF across all available levels at Week 12 and Week 36. |
| 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 | Dysphagia symptom response with respect to the baseline of induction study (SHP621-301 \[NCT02605837\]) was defined as 30% reduction in DSQ combined score (questions 2+3) at Week 12 and Week 36 of current study from baseline of the induction study. DSQ contain 4 questions, all participants used a diary and responded to Q1 (did you eat solid food), Q2 (did food pass slowly or get stuck). If participant's answer to Q2 was No, then diary ended for that day. If participant answered Yes,he/she advanced to Q3 (did you have to do anything to make food go down or get relief) and Q4 (extent to which participant experienced pain while swallowing). DSQ combined score= (\[sum of points from Q2+3 in daily DSQ\] × 14)/Number of diaries reported with non-missing data. Scale range was 0-2 for Q2 and 0-4 for Q3. Scale range for DSQ combined score was 0-84. Higher values representing worse outcome. Negative change from baseline indicates symptoms decreased. |
| 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 | Dysphagia symptom response with respect to the baseline of current study (SHP621-302 \[NCT02736409\]) was defined as 30% reduction in DSQ combined score (questions 2+3) at Week 12 and Week 36 from baseline of the current study. DSQ contain 4 questions, all participants used diary and responded to Q1 (did you eat solid food), Q2 (did food pass slowly or get stuck). If participant's answer to Q2 was "No", then diary ended for that day. If participant answered "Yes",he/she advanced to Q3 (did you have to do anything to make food go down or get relief) and Q4 (extent to which participant experienced pain while swallowing). DSQ combined score= (\[sum of points from Q2+3 in daily DSQ\] × 14)/Number of diaries reported with non-missing data. Scale range was 0-2 for Q2 and 0-4 for Q 3. Scale range for DSQ combined score was 0-84. Higher values representing a worse outcome. A Negative change from baseline indicates symptoms decreased. |
| 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 | Endoscopic findings with separate evaluations of the proximal and distal esophagus were recorded with respect to 5 categories: 1) exudates or plaques (grade 0-2); 2) fixed esophageal rings (grade 0-3); 3) edema (grade 0-2); 4) furrows (grade 0-2); and 5) strictures (grade 0-1). An endoscopy score for each category was calculated and summed for each anatomic location (proximal and distal). The minimum and maximum endoscopy score was 0 and 10 points respectively for each location (proximal and distal) and the total endoscopy score was the sum of the scores for the proximal and distal locations (maximum total score of 20 points respectively). The higher score indicated worse appearance. A negative change from baseline indicates that appearance improved. |
| 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 | Endoscopic findings with separate evaluations of the proximal and distal esophagus were recorded with respect to 5 categories: 1) exudates or plaques (grade 0-2); 2) fixed esophageal rings (grade 0-3); 3) edema (grade 0-2); 4) furrows (grade 0-2); and 5) strictures (grade 0-1). An endoscopy score for each category was calculated and summed for each anatomic location (proximal and distal). The minimum and maximum endoscopy score was 0 and 10 points respectively for each location (proximal and distal) and the total endoscopy score was the sum of the scores for the proximal and distal locations (maximum total score of 20 points respectively). The higher score indicated worse appearance. A negative change from baseline indicates that appearance improved. |
| 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 | Change from induction study (SHP621-301 \[NCT02605837\]) baseline in peak eosinophil count at Week 12 and Week 36 of current study was reported. |
| 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 | Change from current study (SHP621-302 \[NCT02736409\]) baseline in peak eosinophil count at Week 12 and Week 36 was reported. |
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 | 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 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group256
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants Who Had Relapse During the Entire Week 36 Period | Full Responder BOS-PBO Group | 0.43 | proportion of participants | ||
| Proportion of Participants Who Had Relapse During the Entire Week 36 Period | Full Responder BOS-BOS Group | 0.24 | proportion of participants | ||
| Proportion of Participants With Long-term Treatment Response From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 36 of Current Study | Non-Responder BOS-BOS Group | 0.13 | proportion of participants | ||
| Proportion of Participants With Long-term Treatment Response From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 36 | Non-Responder BOS-BOS Group | 0.06 | proportion of participants | ||
| 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 | Full Responder BOS-PBO Group | Week 12 | 0.04 | proportion of participants | |
| 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 | Full Responder BOS-BOS Group | Week 12 | 0.76 | proportion of participants | |
| 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 | Non-Responder BOS-BOS Group | Week 12 | 0.27 | proportion of participants | |
| 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 | PBO-BOS Group | Week 12 | 0.57 | proportion of participants | |
| 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 | Full Responder BOS-PBO Group | Week 36 | 0.30 | proportion of participants | |
| 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 | Full Responder BOS-BOS Group | Week 36 | 0.52 | proportion of participants |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Full Responder BOS-PBO Group | 23 | |
| Overall Study | STARTED | Full Responder BOS-BOS Group | 25 | |
| Overall Study | STARTED | Non-Responder BOS-BOS Group | 106 | |
| Overall Study | STARTED | PBO-BOS Group | 65 | |
| Overall Study | COMPLETED | Full Responder BOS-PBO Group | 19 | |
| Overall Study | COMPLETED | Full Responder BOS-BOS Group | 22 | |
| Overall Study | COMPLETED | Non-Responder BOS-BOS Group | 80 | |
| Overall Study | COMPLETED | PBO-BOS Group | 53 | |
| Overall Study | NOT COMPLETED | Full Responder BOS-PBO Group | 4 | |
| Overall Study | NOT COMPLETED | Full Responder BOS-BOS Group | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events104
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 | Diarrhoea | Gastrointestinal disorders | Full Responder BOS-PBO Group | 1 | 23 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Full Responder BOS-BOS Group | 3 | 25 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Non-Responder BOS-BOS Group | 2 | 106 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | PBO-BOS Group | 4 | 65 | 5 |
| other | Dysphagia | Gastrointestinal disorders | Full Responder BOS-PBO Group | 2 | 23 | 2 |
| other | Dysphagia | Gastrointestinal disorders | Full Responder BOS-BOS Group | 1 | 25 | 1 |
| other | Dysphagia | Gastrointestinal disorders | Non-Responder BOS-BOS Group | 2 | 106 | 2 |
| other | Dysphagia | Gastrointestinal disorders | PBO-BOS Group | 1 | 65 | 1 |
| other | Gastritis | Gastrointestinal disorders | Full Responder BOS-PBO Group | 0 | 23 | 0 |
| other | Gastritis | Gastrointestinal disorders | Full Responder BOS-BOS Group | 4 | 25 | 4 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Full Responder BOS-PBO Group | 0 | 23 |
| Total, all-cause mortality | Full Responder BOS-BOS Group | 0 | 25 |
| Total, all-cause mortality | Non-Responder BOS-BOS Group | 0 | 106 |
| Total, all-cause mortality | PBO-BOS Group | 0 | 65 |
| Total, other adverse events | Full Responder BOS-PBO Group | 9 | 23 |
| Total, other adverse events | Full Responder BOS-BOS Group | 10 | 25 |
| Total, other adverse events | Non-Responder BOS-BOS Group | 26 | 106 |
| Total, other adverse events | PBO-BOS Group | 18 | 65 |
| Total, serious adverse events | Full Responder BOS-PBO Group | 1 | 23 |
| Total, serious adverse events | Full Responder BOS-BOS Group | 0 | 25 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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GET https://conductscience.org/api/trials/v1/NCT02736409/registered?page=2