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Also known as SCH 900222, MK-3222
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...
Top 12 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Johnson & Johnson | JNJ | 11 | PHASE3 | JNJ-77242113, Ustekinumab, Guselkumab |
| Bristol-Myers Squibb Company | BMY | 14 | PHASE3 | Deucravacitinib |
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Risankizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 3 | PHASE3 | Zasocitinib |
| Alumis Inc. | ALMS | 2 | PHASE3 | Envudeucitinib |
| Oruka Therapeutics, Inc. | ORKA | 4 | PHASE2 | ORKA-002, ORKA-001 |
| Can-Fite Biopharma Ltd | CANF | 1 | PHASE3 | Piclidenoson |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Ponesimod |
| Novartis AG Sponsored ADR | NVS | 4 | - | Secukinumab |
| Bausch Health Companies Inc. | BHC | 2 | - | Brodalumab |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-8644 |
Tildrakizumab is being developed for the treatment of moderate-to-severe chronic plaque psoriasis, a skin condition. It is an investigational monoclonal antibody studied in a Phase 2 clinical trial. The drug has not been approved for any indication and remains in clinical development.
Tildrakizumab targets the IL12B and IL23A subunits, which form the interleukin-23 cytokine. By inhibiting IL-23, tildrakizumab is designed to reduce the inflammatory signaling involved in psoriasis. This targeted approach is intended to address the underlying immune response associated with chronic plaque psoriasis.
Tildrakizumab is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is responsible for the clinical development program of this monoclonal antibody for psoriasis.
Tildrakizumab is in Phase 2 clinical development. It has not been approved by the FDA or any regulatory agency and is considered an investigational therapy. The Phase 2 trial has been completed, and further development stages have not been reported.
Tildrakizumab has been studied in one completed Phase 2 clinical trial, NCT01225731. This randomized, double-blind, placebo-controlled study enrolled 355 participants aged 18 years and older with moderate-to-severe chronic plaque psoriasis. The trial evaluated the optimal dose of tildrakizumab.