Trial Outcomes & Findings for A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules (NCT NCT03340961)

NCT ID: NCT03340961

Last Updated: 2021-03-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 205 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2021-03-01

Participant Flow

Participant milestones

Measure	DFD-29 Extended Release Capsules (40 mg) DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (40 mg): Oral Treatment	DFD-29 Extended Release Capsules (20 mg) DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (20 mg): Oral Treatment	Oraycea® (Doxycycline) Capsules Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. Oraycea® (doxycycline) Capsules: Oral Treatment	Placebo Capsules Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment
Overall Study STARTED	53	50	49	53
Overall Study COMPLETED	47	38	40	35
Overall Study NOT COMPLETED	6	12	9	18

Reasons for withdrawal

Measure	DFD-29 Extended Release Capsules (40 mg) DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (40 mg): Oral Treatment	DFD-29 Extended Release Capsules (20 mg) DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (20 mg): Oral Treatment	Oraycea® (Doxycycline) Capsules Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. Oraycea® (doxycycline) Capsules: Oral Treatment	Placebo Capsules Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment
Overall Study Adverse Event	1	1	0	0
Overall Study Lost to Follow-up	0	1	0	1
Overall Study Withdrawal by Subject	3	2	4	7
Overall Study Use of prohibited treatment	0	3	2	4
Overall Study Wrongful enrollment (I/E criteria not me	0	1	0	1
Overall Study Subject developed an exclusion criterion	0	1	0	0
Overall Study Protocol Violation	1	0	1	0
Overall Study Lack of Efficacy	0	0	0	1

Baseline Characteristics

A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules

Baseline characteristics by cohort

Measure	DFD-29 Extended Release Capsules (40 mg) n=53 Participants DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (40 mg): Oral Treatment	DFD-29 Extended Release Capsules (20 mg) n=50 Participants DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (20 mg): Oral Treatment	Oraycea® (Doxycycline) Capsules n=49 Participants Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. Oraycea® (doxycycline) Capsules: Oral Treatment	Placebo Capsules n=53 Participants Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment	Total n=205 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	40 Participants n=7 Participants	40 Participants n=5 Participants	42 Participants n=4 Participants	167 Participants n=21 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	11 Participants n=4 Participants	38 Participants n=21 Participants
Age, Continuous	46.8 years STANDARD_DEVIATION 15.05 • n=5 Participants	51.1 years STANDARD_DEVIATION 13.13 • n=7 Participants	51.6 years STANDARD_DEVIATION 12.94 • n=5 Participants	52.5 years STANDARD_DEVIATION 12.92 • n=4 Participants	50.5 years STANDARD_DEVIATION 13.64 • n=21 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	34 Participants n=7 Participants	29 Participants n=5 Participants	27 Participants n=4 Participants	124 Participants n=21 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	16 Participants n=7 Participants	20 Participants n=5 Participants	26 Participants n=4 Participants	81 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants	50 Participants n=7 Participants	49 Participants n=5 Participants	53 Participants n=4 Participants	205 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment Germany	53 participants n=5 Participants	50 participants n=7 Participants	49 participants n=5 Participants	53 participants n=4 Participants	205 participants n=21 Participants
Total Inflammatory Lesion Count	23.8 Number of lesions STANDARD_DEVIATION 8.69 • n=5 Participants	24.5 Number of lesions STANDARD_DEVIATION 9.49 • n=7 Participants	23.8 Number of lesions STANDARD_DEVIATION 7.56 • n=5 Participants	24.0 Number of lesions STANDARD_DEVIATION 8.40 • n=4 Participants	24.0 Number of lesions STANDARD_DEVIATION 8.51 • n=21 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: The FAS (full analysis set) included all subjects that had at least one post Baseline efficacy assessment.

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.

Outcome measures

Measure	DFD-29 Extended Release Capsules (40 mg) n=53 Participants DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (40 mg): Oral Treatment	DFD-29 Extended Release Capsules (20 mg) n=47 Participants DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (20 mg): Oral Treatment	Oraycea® (Doxycycline) Capsules n=48 Participants Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. Oraycea® (doxycycline) Capsules: Oral Treatment	Placebo Capsules n=52 Participants Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment
Investigator Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe	35 Participants	15 Participants	16 Participants	6 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Population: FAS population

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.

Outcome measures

Measure	DFD-29 Extended Release Capsules (40 mg) n=53 Participants DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (40 mg): Oral Treatment	DFD-29 Extended Release Capsules (20 mg) n=47 Participants DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (20 mg): Oral Treatment	Oraycea® (Doxycycline) Capsules n=48 Participants Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. Oraycea® (doxycycline) Capsules: Oral Treatment	Placebo Capsules n=52 Participants Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment
Total Inflammatory Lesion Count Reduction	-19.2 Count of lesions Standard Deviation 9.72	-12.6 Count of lesions Standard Deviation 12.92	-10.5 Count of lesions Standard Deviation 15.18	-7.3 Count of lesions Standard Deviation 10.12

SECONDARY outcome

Timeframe: Median change in the score from Baseline to Week 16

Population: FAS Population

The RosaQoL assessment is carried out by the Investigator using the validated RosaQoL questionnaire, at every study visit from Screening up to Week 16 (or at early termination). The RosaQol tool has 21 questions related to the impact that Rosacea has on various dimensions influencing quality of life. Each question is graded from 1 (Never) - 5 (All the time), thus leading to a minimum score of 21 (21 x 1) to a maximum score of 105 (21 x 5) per subject at every visit. Higher the score, poorer is the quality of life. This outcome measured the change in the score from Baseline to Week 16.

Outcome measures

Measure	DFD-29 Extended Release Capsules (40 mg) n=53 Participants DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (40 mg): Oral Treatment	DFD-29 Extended Release Capsules (20 mg) n=47 Participants DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (20 mg): Oral Treatment	Oraycea® (Doxycycline) Capsules n=48 Participants Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. Oraycea® (doxycycline) Capsules: Oral Treatment	Placebo Capsules n=52 Participants Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment
Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16	-11.0 score on a scale Interval -53.0 to 11.0	-8.0 score on a scale Interval -34.0 to 8.0	-3.0 score on a scale Interval -30.0 to 25.0	-1.0 score on a scale Interval -37.0 to 19.0

Adverse Events

DFD-29 Extended Release Capsules (40 mg)

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

DFD-29 Extended Release Capsules (20 mg)

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Oraycea® (Doxycycline) Capsules

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo Capsules

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	DFD-29 Extended Release Capsules (40 mg) n=52 participants at risk DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (40 mg): Oral Treatment	DFD-29 Extended Release Capsules (20 mg) n=48 participants at risk DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (20 mg): Oral Treatment	Oraycea® (Doxycycline) Capsules n=48 participants at risk Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. Oraycea® (doxycycline) Capsules: Oral Treatment	Placebo Capsules n=53 participants at risk Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment
Cardiac disorders Coronary artery disease	1.9% 1/52 • Number of events 1 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/48 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/48 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/53 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.
Cardiac disorders Atrial fibrillation	0.00% 0/52 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	2.1% 1/48 • Number of events 1 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/48 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/53 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/52 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/48 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	2.1% 1/48 • Number of events 1 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/53 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.
Nervous system disorders Papilloma	0.00% 0/52 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/48 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	2.1% 1/48 • Number of events 1 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/53 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.
Eye disorders Retinal detachment	0.00% 0/52 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	2.1% 1/48 • Number of events 1 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/48 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/53 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.

Other adverse events

Measure	DFD-29 Extended Release Capsules (40 mg) n=52 participants at risk DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (40 mg): Oral Treatment	DFD-29 Extended Release Capsules (20 mg) n=48 participants at risk DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (20 mg): Oral Treatment	Oraycea® (Doxycycline) Capsules n=48 participants at risk Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. Oraycea® (doxycycline) Capsules: Oral Treatment	Placebo Capsules n=53 participants at risk Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/52 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	6.2% 3/48 • Number of events 3 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	6.2% 3/48 • Number of events 9 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	5.7% 3/53 • Number of events 3 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.
Gastrointestinal disorders Diarrhoea	7.7% 4/52 • Number of events 5 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	8.3% 4/48 • Number of events 4 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/48 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	5.7% 3/53 • Number of events 7 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.
Investigations Nasopharyngitis	21.2% 11/52 • Number of events 11 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	16.7% 8/48 • Number of events 11 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	14.6% 7/48 • Number of events 7 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	17.1% 6/35 • Number of events 8 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/52 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	8.3% 4/48 • Number of events 4 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	8.3% 4/48 • Number of events 6 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	11.3% 6/53 • Number of events 6 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.
Nervous system disorders Headache	42.3% 22/52 • Number of events 47 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	29.2% 14/48 • Number of events 35 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	27.1% 13/48 • Number of events 37 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	24.5% 13/53 • Number of events 29 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/52 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/48 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	0.00% 0/48 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.	7.5% 4/53 • Number of events 4 • AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit. Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded. AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.

Additional Information

Dr. Srinivas Sidgiddi, Senior Director

Dr. Reddy's Lab, INC

Phone: 908-458-5362

Email: Srinivassidgiddi@drreddys.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place