Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DFD-29 · 1 trial · 1 indication
Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16.
The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants.
| Arm | Type | Description |
|---|---|---|
| DFD-29 Extended Release Capsules (40 mg) | EXPERIMENTAL | DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. |
| DFD-29 Extended Release Capsules (20 mg) | EXPERIMENTAL | DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. |
| Oraycea® (doxycycline) Capsules | EXPERIMENTAL | Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. |
| Placebo Capsules | PLACEBO_COMPARATOR | Placebo Capsules once per day for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| DFD-29 Extended Release Capsules (40 mg) | DRUG | Oral Treatment |
| DFD-29 Extended Release Capsules (20 mg) | DRUG | Oral Treatment |
| Oraycea® (doxycycline) Capsules | DRUG | Oral Treatment |
| Placebo Capsules | DRUG | Oral Treatment |
Inclusion Criteria: 1. Subjects must be able to understand the requirements of the study and be willing to give written informed consent. 2. Male and female subjects aged 18 years and above. 3. Subjects, any gender or ethnicity (and of Fitzpatrick skin type I - III), must be in good general health ...
DFD-29 is an investigational oral therapy being developed for the treatment of rosacea, a chronic inflammatory skin condition. It is formulated as extended release capsules at a 40 mg dose and is intended for adults 18 years and older. It has not been approved for any indication.
DFD-29 is being developed by Dr. Reddy's Laboratories Ltd, which trades on the New York Stock Exchange under the ticker RDY. The company is the sponsor of the clinical program evaluating the drug in rosacea.
DFD-29 is in Phase 2 clinical development for rosacea. One Phase 2 trial has been completed, and no trials are currently listed as active. It is an investigational drug and has not been approved by the FDA or any other regulatory authority.
DFD-29 has been evaluated in one completed Phase 2 trial, NCT03340961, titled a controlled study to assess the efficacy, safety and tolerability of oral DFD-29 extended release capsules. The trial enrolled 205 adults with rosacea in Germany and used a randomized, double-blind, placebo-controlled design.
The Phase 2 trial NCT03340961 was a randomized, double-blind, placebo-controlled study of oral DFD-29 extended release capsules in 205 adults with rosacea. It enrolled participants aged 18 years and older of any sex, did not include healthy volunteers, and was conducted in Germany. The study is completed.