Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01276847 | A Study to Assess the Effect of Ustekinumab (Stelara®) and Etanercept (Enbrel®) in Participants With Moderate to Severe Psoriasis (MK-0000-206) | PHASE1 | COMPLETED | 40 | — | — | Mar 1, 2011 | Dec 1, 2011 | Jan 26, 2015 | - | — |
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 ...