Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Ustekinumab is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. FDA label
Also known as STELARA
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 is a monoclonal antibody developed by Johnson & Johnson for the treatment of moderately to severely active ulcerative colitis, a form of inflammatory bowel disease affecting the colon. It is being studied in pediatric patients aged 2 years and older. The Phase 3 trial in this indication has been completed.
Ustekinumab targets the p40 subunit shared by the cytokines IL-12 and IL-23, binding the IL12B gene product and thereby inhibiting IL-12 and IL-23 signaling. Its molecular targets include IL12B, IL12A, and IL23A. It acts as an inhibitor of this pathway, which is involved in inflammatory immune responses.
Ustekinumab is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the sponsor behind the clinical development program for the drug in ulcerative colitis.
Ustekinumab is in Phase 3 development for moderately to severely active ulcerative colitis in pediatric patients. The Phase 3 trial has been completed. It is an investigational use in this pediatric population and is not described here as approved for this indication.
The Phase 3 trial for ustekinumab in pediatric ulcerative colitis is NCT04630028, titled A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis. It was a completed, randomized, double-blind, controlled trial that enrolled 112 participants across the United States, Belgium, Germany, Hungary, Israel, Japan, Poland, Russia, and the United Kingdom.
Ustekinumab dosing in the pediatric ulcerative colitis study was based on body surface area and body weight. The Phase 3 trial NCT04630028 enrolled 112 pediatric participants aged 2 years and older with moderately to severely active ulcerative colitis, and it has been completed.