Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MMX Mesalamine · 2 trials · 1 indication
Clinical response was defined as partial ulcerative colitis disease activity index (UC-DAI) score \< or =1 with rectal bleeding = 0, stool frequency \< or =1, and physician's global assessment (PGA = 0). Number of participants with clinical response were reported.
Clinical response was defined as partial UC-DAI \<=1 with (rectal bleeding = 0, stool frequency \< or =1, and PGA = 0). Number of participants who had maintained clinical response were reported.
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Clearance of a substance from the blood by the kidneys.
| Arm | Type | Description |
|---|---|---|
| MMX Mesalamine/Mesalazine (Low Dose) | EXPERIMENTAL | Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (\<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (\>) 23 kg to \<= 35 kg; 1800 mg/day for participants weighing \> 35 kg to \<= 50 kg; 2400 mg/day for participants weighing \> 50 kg to \<= 90 kg. |
| MMX Mesalamine/Mesalazine (High Dose) | EXPERIMENTAL | Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to \<= 23 kg; 2400 mg/day for participants weighing \> 23 kg to \<= 35 kg; 3600 mg/day for participants weighing \> 35 kg to \<= 50 kg; 4800 mg/day for participants weighing \> 50 kg to \<= 90 kg. |
| MMX Mesalamine (30mg/kg) | EXPERIMENTAL | - |
| MMX Mesalamine (60 mg/kg) | EXPERIMENTAL | - |
| MMX Mesalamine (100 mg/kg) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MMX Mesalamine/Mesalazine (Low Dose) | DRUG | Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (\<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (\>) 23 kg to \<= 35 kg; 1800 mg/day for participants weighing \> 35 kg to \<= 50 kg; 2400 mg/day for participants weighing \> 50 kg to \<= 90 kg. |
| MMX Mesalamine/Mesalazine (High Dose) | DRUG | Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to \<= 23 kg; 2400 mg/day for participants weighing \> 23 kg to \<= 35 kg; 3600 mg/day for participants weighing \> 35 kg to \<= 50 kg; 4800 mg/day for participants weighing \> 50 kg to \<= 90 kg. |
| MMX Mesalamine | DRUG | 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. |
Inclusion Criteria: 1. Ability to voluntarily provide written, signed, and dated (personally or via a legally authorized representative \[LAR\]) informed consent or assent as applicable to participate in the study. 2. Subject's parent/LAR demonstrates an understanding, ability, and willingness to f...
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MMX Mesalamine is used to treat ulcerative colitis, a form of inflammatory bowel disease. The clinical program covers pediatric subjects with mild to moderate ulcerative colitis. It is a small molecule therapy in the gastrointestinal therapeutic area, developed by Takeda Pharmaceutical Company Limited.
MMX Mesalamine is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical trials evaluating the drug in ulcerative colitis.
MMX Mesalamine is in Phase 3 development for ulcerative colitis. It is an investigational therapy and is not approved. Two trials have been completed, including a Phase 3 safety and efficacy study and a Phase 1 safety and pharmacokinetics study.
Two completed trials have evaluated MMX Mesalamine. NCT02093663 was a Phase 3 study of safety and efficacy in pediatric subjects with mild to moderate ulcerative colitis, enrolling 107 participants. NCT01130844 was a Phase 1 study of safety and pharmacokinetics in children and adolescents with ulcerative colitis, enrolling 52 participants.
The MMX Mesalamine clinical program enrolled 159 participants across two completed trials. NCT02093663 enrolled 107 pediatric subjects with mild to moderate ulcerative colitis, and NCT01130844 enrolled 52 children and adolescents. Both studies were randomized, double blind, and controlled.