Trial · NCT03290781
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Remission Based on Composite Score at Week 52 | At Week 52 | The ontamalimab responder full analysis set (FAS) consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Endoscopic Remission at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder FAS only (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained Remission at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response Based on Composite Score at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Glucocorticoid-free Clinical Remission at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Glucocorticoid-free Remission at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Remission Based on Total Mayo Score at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0 | At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained Endoscopic Remission at Week 52 | At Week 52 | The ontamalimab responder FAS consisted of all participants in the randomized set who received at least 1 dose of IP in this study and who were previously treated with ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). As Pre-specified in protocol all the efficacy analyses data were collected and analyzed based on ontamalimab responder (i.e ONTA 25mg/ Placebo, ONTA 25mg/ONTA 25mg, ONTA 75mg/Placebo and ONTA 75mg/ONTA 75mg arms only). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of study drug administration up to follow-up (Week 64) | The safety set consisted of all participants who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab | At Week 12, 24, 36 and 52 | The safety set consisted of all participants who had received at least 1 dose of IP in this study, regardless of treatment received during the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed refer to the participants evaluable at specific time points. | Participants | COUNT_OF_PARTICIPANTS |
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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