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Ontamalimab · 2 trials · 2 indications
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).
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) were defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product.
Serious infections were defined as any infections that were life-threatening or those requiring hospitalization or intravenous antibiotics based on the investigator's assessment.
Clinical laboratory assessments included hematology, serum chemistry and urinalysis. Any notable changes in the clinical laboratory value over time based on the investigator interpretation were reported.
ECG included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals parameters measurement. Any discernible changes in the ECG value over time based on investigator interpretation were reported.
Vital sign assessments included blood pressure, pulse, respiratory rate, and temperature. Any discernible changes in vital signs over time per investigator interpretation were reported.
| 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. |
| Ulcerative Colitis (UC): Ontamalimab 25 mg | EXPERIMENTAL | Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years. |
| UC: Ontamalimab 25mg then 75 mg | EXPERIMENTAL | Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years. |
| UC: Ontamalimab 75 mg | EXPERIMENTAL | Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years. |
| Crohn's disease (CD): Ontamalimab 25 mg | EXPERIMENTAL | Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years. |
| CD: Ontamalimab 25mg then 75 mg | EXPERIMENTAL | Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years. |
| CD: Ontamalimab 75 mg | EXPERIMENTAL | Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years. |
| 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. |
| 25 mg Ontamalimab | DRUG | Ontamalimab SC solution for injection |
| 75 mg Ontamalimab | DRUG | Ontamalimab SC solution for injection |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Risankizumab On-Body Injector |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Ontamalimab is an investigational drug being studied for the treatment of moderate to severe ulcerative colitis and Crohn's disease, both of which are inflammatory bowel diseases. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Ontamalimab is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with ulcerative colitis and Crohn's disease.
Ontamalimab is in Phase 3 clinical development. It has completed two Phase 3 trials, including a safety extension study and a maintenance therapy study, both in patients with moderate to severe ulcerative colitis or Crohn's disease. The drug remains investigational and is not yet approved.
Ontamalimab has been studied in two completed Phase 3 trials. The first, NCT03283085, was a safety extension study in patients with moderate to severe ulcerative colitis or Crohn's disease, enrolling 557 participants. The second, NCT03290781, evaluated the drug as maintenance therapy in 366 patients with moderate to severe ulcerative colitis.
Ontamalimab is not known to have alternative names. It is a distinct investigational compound being developed by Takeda for the treatment of inflammatory bowel diseases, including ulcerative colitis and Crohn's disease.