A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.

A Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05296629

Acronym

MVOR-1

Enrollment

323

Registered

2022-03-25

Start date

2022-03-14

Completion date

2023-06-30

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papulopustular Rosacea

Brief summary

Detailed description

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. Subject visits are scheduled at Screening, Baseline (Day 1), and Weeks 2, 4, 8, 12, and 16. Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment modified scale without erythema (IGA), Clinician's Erythema Assessment (CEA), and total inflammatory lesion count at Weeks 2, 4, 8, 12, and 16 compared to Baseline. Laboratory assessments of blood (hematology and biochemistry) and urine (routine tests) will be conducted at Screening and Week 16 (end of study \[EOS\] or early termination) to assess for any changes in the safety parameters. Other safety assessments include vital signs, physical examination, urine pregnancy tests (for females of childbearing potential), and collection of AE data. The impact of the treatment on the quality of life (QoL) of the subjects will be assessed using the rosacea-specific tool RosaQoL in addition to the Dermatology Life Quality Index (DLQI) at Baseline and Weeks 2, 4, 8, 12, and 16.

Interventions

DRUGDFD-29

DFD-29 (40 mg) extended release capsules

DRUGDoxycycline

Doxycycline 40 mg capsules

DRUGPlacebo

Placebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

A multicenter, randomized, parallel-group, double-blind, controlled study.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Male and female subjects aged 18 years and above. * Subjects must be in good general health as determined by the investigator and supported by the medical history. * Subjects must have a clinical diagnosis of papulopustular rosacea with IGA grade 3 (moderate) or IGA grade 4 (severe) at Baseline. * Subjects must have 15 to 60 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face at Baseline. * Subjects must have not more than 2 nodules or cysts at Baseline. Key

Exclusion criteria

* Female subjects who are pregnant or nursing or planning to become pregnant during the study. * Male subjects whose female partner is planning to conceive a child. * Clinically significant abnormal laboratory test results that, in the opinion of the investigator, would compromise the subject's safety or ability to participate in the trial. * History of organ transplant requiring immunosuppression, HIV, or other immune compromised state. * History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness. * Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.

Design outcomes

Primary

Measure	Time frame	Description
Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.	Baseline to Week 16.	Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome.
Change in Total Inflammatory Lesion Count Compared to Placebo.	Baseline to Week 16.	Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.

Secondary

Measure	Time frame	Description
IGA Treatment Success Compared to Doxycycline.	Baseline to Week 16.	Proportion of subjects with IGA treatment success at week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
Change in Total Inflammatory Lesion Count Compared to Doxycycline.	Baseline to Week 16.	Total inflammatory lesion count change from Baseline to week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
Clinician's Erythema Assessment (CEA) Compared to Placebo.	Baseline to Week 16.	Proportion of subjects with at least 2-grade reduction in CEA score from Baseline to Week 16 in the DFD-29 group compared to Placebo.

Countries

United States

Participant flow

Participants by arm

Arm	Count
DFD-29 DFD-29 (40 mg) extended release capsules DFD-29: DFD-29 (40 mg) extended release capsules	122
Doxycycline 40 mg Capsule Doxycycline 40 mg capsule administered once daily for 16 weeks	121
Placebo Placebo capsules matching DFD-29 Placebo: Placebo capsules	80
Total	323

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	0	4	2
Overall Study	Lost to Follow-up	2	7	1
Overall Study	Protocol Violation	0	2	0
Overall Study	Withdrawal by Subject	3	10	4

Baseline characteristics

Characteristic	Doxycycline 40 mg Capsule	Total	Placebo	DFD-29
Age, Continuous	46.7 years STANDARD_DEVIATION 14.11	47.2 years STANDARD_DEVIATION 13.72	47.2 years STANDARD_DEVIATION 14.09	47.7 years STANDARD_DEVIATION 13.16
Clinician's Erythema Assessment (CEA) score 0 = None	0 Participants	0 Participants	0 Participants	0 Participants
Clinician's Erythema Assessment (CEA) score 1 = Mild	2 Participants	7 Participants	2 Participants	3 Participants
Clinician's Erythema Assessment (CEA) score 2 = Moderate	45 Participants	127 Participants	32 Participants	50 Participants
Clinician's Erythema Assessment (CEA) score 3 = Significant	61 Participants	155 Participants	37 Participants	57 Participants
Clinician's Erythema Assessment (CEA) score 4 = Severe	13 Participants	34 Participants	9 Participants	12 Participants
Investigators Global Assessment (IGA) grade Moderate	110 Participants	279 Participants	68 Participants	101 Participants
Investigators Global Assessment (IGA) grade Severe	11 Participants	44 Participants	12 Participants	21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) Asian	5 Participants	17 Participants	6 Participants	6 Participants
Race (NIH/OMB) Black or African American	3 Participants	4 Participants	0 Participants	1 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	5 Participants	1 Participants	2 Participants
Race (NIH/OMB) White	111 Participants	295 Participants	71 Participants	113 Participants
Region of Enrollment United States	121 participants	323 participants	80 participants	122 participants
Sex: Female, Male Female	90 Participants	247 Participants	63 Participants	94 Participants
Sex: Female, Male Male	31 Participants	76 Participants	17 Participants	28 Participants
Total Inflammatory Lesion Count	23.8 Lesion count STANDARD_DEVIATION 8.75	25.3 Lesion count STANDARD_DEVIATION 9.5	25.9 Lesion count STANDARD_DEVIATION 8.84	26.4 Lesion count STANDARD_DEVIATION 10.46

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 121	0 / 116	0 / 76
other Total, other adverse events	17 / 121	19 / 116	18 / 76
serious Total, serious adverse events	0 / 121	0 / 116	0 / 76

Outcome results

Primary

Change in Total Inflammatory Lesion Count Compared to Placebo.

Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.