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DFD06 · 3 trials · 2 indications
The primary efficacy endpoint is the percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at the Day 15 visit. The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2-grade reduction from baseline) at the Day 15 visit. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)
| Arm | Type | Description |
|---|---|---|
| DFD-06 cream | EXPERIMENTAL | DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. |
| Vehicle Cream | PLACEBO_COMPARATOR | Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. |
| Clobetasol Propionate Cream, 0.05% | ACTIVE_COMPARATOR | applied twice a day for 15 days |
| DFD06 Cream | EXPERIMENTAL | applied twice a day for 15 days |
| Name | Type | Description |
|---|---|---|
| DFD06-Cream | DRUG | Twice daily topical application for 14 days. |
| Vehicle Cream | DRUG | Twice daily topical application for 14 days. |
| DFD06 Cream | DRUG | Twice daily topical application for 14 days. |
| Clobetasol Propionate Cream 0.05% | DRUG | - |
Inclusion Criteria: 1. Subject understands the study procedures and agrees to participate by giving written informed consent. Subjects must be willing to authorize use and disclosure of protected health information collected for the study. 2. Subject must be at least 18 years of age. 3. Subject mus...
DFD06 is an investigational small molecule cream being developed for the treatment of chronic stable plaque psoriasis and psoriasis. It is intended for patients with moderate to severe plaque psoriasis, as studied in clinical trials. The drug is applied topically and is currently in clinical development, not yet approved by regulatory authorities.
DFD06 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company has conducted clinical trials for this investigational cream in the United States, focusing on its efficacy and safety in treating moderate to severe plaque psoriasis.
DFD06 is in Phase 3 clinical development for the treatment of moderate to severe plaque psoriasis. Two Phase 3 trials have been completed, along with one Phase 2 study. The drug remains investigational and has not received FDA approval, as it is still undergoing clinical evaluation to establish its safety and efficacy profile.
DFD06 has been studied in three completed clinical trials. NCT02131324 was a Phase 2 study comparing DFD06 cream to clobetasol propionate cream in patients with moderate to severe plaque psoriasis. NCT02445807 and NCT02635204 were Phase 3 trials evaluating the efficacy and safety of DFD06 cream in the same patient population.
No, DFD06 is not the same as clobetasol propionate. In clinical trials, DFD06 cream was compared against clobetasol propionate cream, 0.05%, as an active comparator. DFD06 is a distinct investigational small molecule formulation being developed by Dr. Reddy's Laboratories, while clobetasol propionate is a well-established topical corticosteroid used for psoriasis treatment.
The specific molecular target or mechanism of action for DFD06 has not been disclosed in available clinical trial information. It is described as a small molecule cream intended for topical application in treating moderate to severe plaque psoriasis. The exact biological pathway through which it exerts its therapeutic effect remains unspecified in public data.