Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ustekinumab Dose Based on BSA and Body Weight · 1 trial · 1 indication
Clinical remission is defined as Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.
Number of Participants with discontinuation of study intervention due to an AE, infections, injection-site reactions, and AEs during or within 1 hour of an infusion will be reported.
AESI of any newly identified malignancy, case of active tuberculosis (TB), or opportunistic infection occurring after the first administration of study intervention(s) in participants will be reported.
Number of participants with laboratory abnormalities related to hematology, serum chemistry, and coagulation will be reported.
Reactions temporally associated with an IV infusion (induction period) and SC injection-site reactions (maintenance period) will be reported.
Serum samples will be analyzed to determine concentrations of ustekinumab.
Clinical remission at M-44 for participants who are in clinical response at I-8 will be reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
| Arm | Type | Description |
|---|---|---|
| Induction Period (I): Ustekinumab | EXPERIMENTAL | All participants will receive a single intravenous (IV) administration of ustekinumab at induction Week 0 (I-0) based on body surface area (BSA) (milligram per meter square \[mg/m\^2\]) or weight-tiered induction dose (milligram per kilogram \[mg/kg\]). |
| Maintenance (M) Period: Ustekinumab once every 8 Week (q8w) | EXPERIMENTAL | Participants will receive subcutaneous (SC) administration of ustekinumab every 8 weeks (q8w) based on BSA (mg/m\^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-8, M-16, M-24, M-32, M-40 and matching placebo at Weeks M-12 and M-36 to maintain the blind. |
| Maintenance (M) Period: Ustekinumab once every 12 Week (q12w) | EXPERIMENTAL | Participants will receive SC administration of ustekinumab every 12 weeks (q12w) based on BSA (mg/m\^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-12, M-24, M-36 and matching placebo at Weeks M-8, M-16, M-32, and M-40 to maintain the blind. |
| Name | Type | Description |
|---|---|---|
| Ustekinumab Dose Based on BSA and Body Weight | DRUG | As per BSA and body weight Ustekinumab will be administered SC and IV. |
| Matching Placebo | DRUG | Placebo will be administered subcutaneously. |
Inclusion Criteria: * Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documen...
Ustekinumab Dose Based on BSA and Body Weight is an investigational small molecule being studied for the treatment of moderately to severely active ulcerative colitis in pediatric participants. It is being developed by Johnson & Johnson (JNJ) and is currently in Phase 3 clinical development.
The molecular target for Ustekinumab Dose Based on BSA and Body Weight has not been disclosed. The drug is being investigated for its potential to treat ulcerative colitis, a chronic inflammatory bowel disease, but its specific mechanism of action is not publicly available.
Ustekinumab Dose Based on BSA and Body Weight is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in pediatric patients with ulcerative colitis.
Ustekinumab Dose Based on BSA and Body Weight is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being evaluated for the treatment of moderately to severely active ulcerative colitis in pediatric participants.
Ustekinumab Dose Based on BSA and Body Weight has one completed Phase 3 clinical trial, identified as NCT04630028. This randomized, double-blind, controlled study enrolled 112 pediatric participants with moderately to severely active ulcerative colitis across multiple countries, including the United States, Belgium, Germany, Hungary, Israel, Japan, Poland, Russia, and the United Kingdom.