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Also known as TCS Cream
TCS · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Lebrikizumab 250 mg Single Dose + TCS Cream | EXPERIMENTAL | Participants will receive lebrikizumab 250 milligrams (mg) SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period. |
| Lebrikizumab 125 mg Single Dose + TCS Cream | EXPERIMENTAL | Participants will receive lebrikizumab 125 mg SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period. |
| Lebrikizumab 125 mg Q4W + TCS Cream | EXPERIMENTAL | Participants will receive lebrikizumab 125 mg SC every 4 weeks (Q4W) for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period. |
| Placebo Q4W + TCS Cream | PLACEBO_COMPARATOR | Participants will receive placebo Q4W for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period. |
| Name | Type | Description |
|---|---|---|
| Lebrikizumab | DRUG | Lebrikizumab will be administered SC as per the schedule specified in the respective arms. |
| Placebo | DRUG | Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms. |
| TCS Cream | DRUG | TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily |
Inclusion Criteria: * AD diagnosed by the Hanifin/Rajka criteria and that has been present for at least 1 year at screening * Moderate to severe AD as graded by the Rajka/Langeland criteria at screening * History of inadequate response to a \>/= 1 month (within the 3 months prior to the screening v...
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TCS is being studied for the treatment of atopic dermatitis, also known as eczema. It is an investigational small molecule developed by Roche Holding AG. The clinical program has focused on moderate to severe atopic dermatitis in adults, and the drug has not been approved for any indication.
TCS is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating the drug in atopic dermatitis.
TCS is in Phase 2 clinical development for atopic dermatitis. One Phase 2 trial has been completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.
TCS has been evaluated in one completed Phase 2 trial, NCT02340234, titled A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis. The trial enrolled 212 participants across the United States, Australia, Canada, Czechia, Finland, France, Germany, Netherlands, Poland, South Korea, Spain, Switzerland, Taiwan, and the United Kingdom.
Yes, TCS Cream is another name for TCS. Both names refer to the same investigational small molecule being developed by Roche Holding AG for atopic dermatitis.
The Phase 2 trial NCT02340234 was a randomized, double-blind, placebo-controlled study of TCS in adults with persistent moderate to severe atopic dermatitis. It enrolled 212 participants aged 18 years and older of all sexes, and it did not select patients based on a biomarker. The trial is completed.