Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
tildrakizumab · 1 trial · 1 indication
The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as \>=75% improvement in PASI score when compared to the baseline score.
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Participants may be discontinued from study drug due to adverse events, but remain on the study.
| Arm | Type | Description |
|---|---|---|
| Part 1: Tildrakizumab 5 mg | EXPERIMENTAL | Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4 |
| Part 1: Tildrakizumab 25 mg | EXPERIMENTAL | Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4 |
| Part 1: Tildrakizumab 100 mg | EXPERIMENTAL | Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4 |
| Part 1: Tildrakizumab 200 mg | EXPERIMENTAL | Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4 |
| Part 1: Placebo | PLACEBO_COMPARATOR | Participants receive placebo, SC, at Weeks 0 and 4 |
| Part 2: Tildrakizumab 5 mg | EXPERIMENTAL | Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks |
| Part 2: Tildrakizumab 25 mg | EXPERIMENTAL | Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks |
| Part 2: Tildrakizumab 100 mg | EXPERIMENTAL | Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks |
| Part 2: Tildrakizumab 200 mg | EXPERIMENTAL | Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks |
| Part 3: Tildrakizumab 5 mg Follow-up | NO_INTERVENTION | Participants are followed for up to 20 weeks after the last dose of study drug. |
| Part 3: Tildrakizumab 25 mg Follow-up | NO_INTERVENTION | Participants are followed for up to 20 weeks after the last dose of study drug. |
| Part 3: Tildrakizumab 100 mg Follow-up | NO_INTERVENTION | Participants are followed for up to 20 weeks after the last dose of study drug. |
| Part 3: Tildrakizumab 200 mg Follow-up | NO_INTERVENTION | Participants are followed for up to 20 weeks after the last dose of study drug. |
| Part 3: Placebo Follow-up | NO_INTERVENTION | Participants are followed for up to 20 weeks after the last dose of study drug. |
| Name | Type | Description |
|---|---|---|
| tildrakizumab | BIOLOGICAL | SC administration of tildrakizumab at assigned dose |
| Placebo | DRUG | SC administration of Placebo |
Inclusion Criteria: * Adult participants (≥18 years of age) with a diagnosis of moderate-to-severe chronic plaque psoriasis (defined by ≥10% body surface area \[BSA\] involvement, "moderate" or greater score on the Physician's Global Assessment \[PGA\] scale, and PASI score ≥12 at Baseline) * Parti...
Tildrakizumab is a monoclonal antibody being developed for the treatment of moderate-to-severe chronic plaque psoriasis. It is currently in Phase 2 clinical development and is considered investigational, meaning it has not been approved by regulatory authorities for this use.
Tildrakizumab is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being studied for its potential to treat moderate-to-severe chronic plaque psoriasis, a condition involving inflammation and skin cell overproduction.
Tildrakizumab is being developed by Merck & Company, Inc., which is publicly traded 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 chronic plaque psoriasis.
Tildrakizumab is currently in Phase 2 clinical development. It has completed one Phase 2 trial, and there are no active trials listed at this time. The drug is investigational and has not been approved by the FDA or other regulatory agencies.
Tildrakizumab has been studied in one completed Phase 2 clinical trial with the identifier NCT01225731. This trial, titled 'A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)', enrolled 355 participants and was a randomized, double-blind, placebo-controlled study.
Yes, tildrakizumab is also known as SCH 900222 and MK-3222. These alternative names appear in the clinical trial title for the Phase 2 study, which refers to tildrakizumab as SCH 900222/MK-3222. This helps identify the drug across different stages of its development.