Approval Probability
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Adjusted LOA
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Ustekinumab · 1 trial · 1 indication
Skin biopsies were collected from participants at baseline and after treatment with ustekinumab for 1,2,4 and 16 weeks. The expression of messenger RNA (mRNA) from three pre-defined IL-12 pathway related genes, modulated by interferon gamma (IFN-γ), namely IFN-γ, inducible nitric oxide synthase(iNOS) and CXC motif chemokine 10(CXCL10) was quantitated by real-time polymerase chain reaction (qPCR), with the data normalized by the delta-delta Ct method. The expression score for each gene, showing the percentage difference from baseline, was calculated as follows : \[(baseline - post baseline)/baseline\] x 100. Composite gene expression scores were derived for each individual by summing the expression scores of the individual genes. Positive composite scores denote a decrease from baseline in gene expression.
| Arm | Type | Description |
|---|---|---|
| Ustekinumab | EXPERIMENTAL | - |
| Etanercept | ACTIVE_COMPARATOR | - |
| No treatment | NO_INTERVENTION | - |
| Name | Type | Description |
|---|---|---|
| Ustekinumab | DRUG | Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing \> 100 kg on Day 1, and Weeks 4 and 16 |
| Etanercept | DRUG | Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks |
Inclusion Criteria: * Is unlikely to conceive (for female participants of reproductive potential)- Part 2 * Has a diagnosis of predominantly plaque psoriasis for ≥ 6 months-Parts 1 and 2 * Has a plaque-type psoriatic lesion with a Target Lesion Score (TLS) score of ≥ 6 in a hidden area of the body ...
Ustekinumab is a small molecule being studied for the treatment of moderate to severe psoriasis. It is currently in Phase 1 clinical development and is not yet approved for this indication. The drug is being investigated as an active-controlled treatment, meaning it is compared against another active therapy in clinical trials.
Ustekinumab is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with moderate to severe psoriasis.
Ustekinumab is in Phase 1 clinical development for psoriasis. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 40 participants, and no active trials are currently listed.
Ustekinumab has one completed clinical trial registered under NCT01276847, titled "A Study to Assess the Effect of Ustekinumab (Stelara®) and Etanercept (Enbrel®) in Participants With Moderate to Severe Psoriasis (MK-0000-206)." This Phase 1 study enrolled 40 participants and was active-controlled, comparing Ustekinumab to Etanercept.
Ustekinumab is the same as Stelara, as indicated by the clinical trial title that references Ustekinumab (Stelara®). The trial compares Ustekinumab to Etanercept (Enbrel®) in participants with moderate to severe psoriasis, confirming that Stelara is the brand name for Ustekinumab.