Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03290781 | An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis | PHASE3 | COMPLETED | 366 | — | — | Apr 4, 2018 | Jul 1, 2021 | Jan 14, 2022 | 401 | United States, Argentina +35 |
Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood \& 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
| Arm | Type | Description |
|---|---|---|
| Ontamalimab 25 mg | EXPERIMENTAL | Participants will receive 25 milligram (mg) of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) will receive 25 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52. |
| Ontamalimab 75 mg | EXPERIMENTAL | Participants will receive 75 mg of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) will receive 75 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 25 mg or 75 mg ontamalimab or placebo matched to ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) will receive placebo matched to ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52. |
| Name | Type | Description |
|---|---|---|
| Ontamalimab | DRUG | Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg). |
| Placebo | OTHER | Participants will receive 1 mL of sterile aqueous buffered solution. |
Inclusion Criteria: * Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions. * Participants must be able to voluntarily provide written, signed, and dated (personally or via a...