A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
Summary
This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks. Of the 320 subjects, approximately 160 subjects are planned to be enrolled at 15 sites in the US, while the remaining subjects are to be enrolled at 14 sites in the EU.
Timeline
- Start
- 2022-03-29
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
Outcome
Met primary endpoint
paper DFD-29 demonstrated superior efficacy in IGA success rates compared with placebo PMID 40042869 ↗
paper MVOR-2: TD, 34.1%; 95% CI, 21.3-46.8; P < .001 PMID 40042869 ↗
paper DFD-29 also showed superior efficacy in least-squares mean reductions in total inflammatory lesions vs placebo PMID 40042869 ↗
paper MVOR-2: TD, -6.8; 95% CI, -8.9 to -4.8; P < .001 PMID 40042869 ↗
release “MVOR-2 Topline Results In the DFD-29 group, 60.1% of subjects demonstrated IGA success, while 31.4% showed IGA success in the Oracea group” journeymedicalcorp.com ↗
release “Both clinical trials achieved the co-primary and all secondary endpoints” journeymedicalcorp.com ↗
release “Both clinical trials achieved the co-primary and all secondary endpoints” journeymedicalcorp.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DFD-29 | Unknown | 40 mg | Oral |
| Comparator | Doxycycline | Small molecule | 40 mg | Oral |