Trial Outcomes & Findings for Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris (NCT NCT01628549)

NCT ID: NCT01628549

Last Updated: 2019-02-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 285 participants
• Primary outcome timeframe: Baseline (Week 0) to Final Visit (Up to Week 12)
• Results posted on: 2019-02-01

Participant Flow

Participant milestones

Measure	Placebo Two placebo capsules matching P005672-HCl, taken orally each day	P005672-HCl Approximately 0.75 mg/kg/Day One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	P005672-HCl Approximately 1.5 mg/kg/Day Two P005672-HCl 50 mg capsules, taken orally each day	P005672-HCl Approximately 3.0 mg/kg/Day Two P005672-HCl 100 mg capsules, taken orally each day
Overall Study STARTED	73	76	70	66
Overall Study COMPLETED	64	64	60	57
Overall Study NOT COMPLETED	9	12	10	9

Reasons for withdrawal

Measure	Placebo Two placebo capsules matching P005672-HCl, taken orally each day	P005672-HCl Approximately 0.75 mg/kg/Day One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	P005672-HCl Approximately 1.5 mg/kg/Day Two P005672-HCl 50 mg capsules, taken orally each day	P005672-HCl Approximately 3.0 mg/kg/Day Two P005672-HCl 100 mg capsules, taken orally each day
Overall Study Adverse Event	1	1	0	4
Overall Study Lost to Follow-up	3	4	3	3
Overall Study Withdrawal by Subject	3	4	4	1
Overall Study Protocol Violation	2	1	1	0
Overall Study withdrawn for noncompliance	0	2	1	0
Overall Study abnormal laboratory test results	0	0	1	0
Overall Study positive pregnancy test	0	0	0	1

Baseline Characteristics

Five subjects in the Safety Population checked multiple races.

Baseline characteristics by cohort

Measure	Placebo n=73 Participants Two placebo capsules matching P005672-HCl, taken orally each day	P005672-HCl Approximately 0.75 mg/kg/Day n=76 Participants One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	P005672-HCl Approximately 1.5 mg/kg/Day n=70 Participants Two P005672-HCl 50 mg capsules, taken orally each day	P005672-HCl Approximately 3.0 mg/kg/Day n=66 Participants Two P005672-HCl 100 mg capsules, taken orally each day	Total n=285 Participants Total of all reporting groups
Age, Continuous	20.8 Years STANDARD_DEVIATION 6.99 • n=5 Participants	19.7 Years STANDARD_DEVIATION 5.92 • n=7 Participants	19.9 Years STANDARD_DEVIATION 7.04 • n=5 Participants	20.3 Years STANDARD_DEVIATION 7.11 • n=4 Participants	20.2 Years STANDARD_DEVIATION 6.74 • n=21 Participants
Sex/Gender, Customized Male	25 Participants n=5 Participants	29 Participants n=7 Participants	30 Participants n=5 Participants	29 Participants n=4 Participants	113 Participants n=21 Participants
Sex/Gender, Customized Female	48 Participants n=5 Participants	47 Participants n=7 Participants	40 Participants n=5 Participants	37 Participants n=4 Participants	172 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	19 Participants n=5 Participants	21 Participants n=7 Participants	16 Participants n=5 Participants	19 Participants n=4 Participants	75 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	54 Participants n=5 Participants	55 Participants n=7 Participants	54 Participants n=5 Participants	47 Participants n=4 Participants	210 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants • Five subjects in the Safety Population checked multiple races.	0 Participants n=7 Participants • Five subjects in the Safety Population checked multiple races.	0 Participants n=5 Participants • Five subjects in the Safety Population checked multiple races.	1 Participants n=4 Participants • Five subjects in the Safety Population checked multiple races.	2 Participants n=21 Participants • Five subjects in the Safety Population checked multiple races.
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants • Five subjects in the Safety Population checked multiple races.	4 Participants n=7 Participants • Five subjects in the Safety Population checked multiple races.	3 Participants n=5 Participants • Five subjects in the Safety Population checked multiple races.	1 Participants n=4 Participants • Five subjects in the Safety Population checked multiple races.	12 Participants n=21 Participants • Five subjects in the Safety Population checked multiple races.
Race/Ethnicity, Customized Black or African American	17 Participants n=5 Participants • Five subjects in the Safety Population checked multiple races.	18 Participants n=7 Participants • Five subjects in the Safety Population checked multiple races.	21 Participants n=5 Participants • Five subjects in the Safety Population checked multiple races.	13 Participants n=4 Participants • Five subjects in the Safety Population checked multiple races.	69 Participants n=21 Participants • Five subjects in the Safety Population checked multiple races.
Race/Ethnicity, Customized Native Hawaiian or Other Pacific islander	0 Participants n=5 Participants • Five subjects in the Safety Population checked multiple races.	0 Participants n=7 Participants • Five subjects in the Safety Population checked multiple races.	0 Participants n=5 Participants • Five subjects in the Safety Population checked multiple races.	0 Participants n=4 Participants • Five subjects in the Safety Population checked multiple races.	0 Participants n=21 Participants • Five subjects in the Safety Population checked multiple races.
Race/Ethnicity, Customized White	54 Participants n=5 Participants • Five subjects in the Safety Population checked multiple races.	55 Participants n=7 Participants • Five subjects in the Safety Population checked multiple races.	46 Participants n=5 Participants • Five subjects in the Safety Population checked multiple races.	52 Participants n=4 Participants • Five subjects in the Safety Population checked multiple races.	207 Participants n=21 Participants • Five subjects in the Safety Population checked multiple races.
Height	165.80 cm STANDARD_DEVIATION 10.436 • n=5 Participants	167.49 cm STANDARD_DEVIATION 9.047 • n=7 Participants	167.23 cm STANDARD_DEVIATION 7.380 • n=5 Participants	167.33 cm STANDARD_DEVIATION 9.764 • n=4 Participants	166.96 cm STANDARD_DEVIATION 9.206 • n=21 Participants
Weight at Baseline	68.47 kg STANDARD_DEVIATION 10.306 • n=5 Participants	66.37 kg STANDARD_DEVIATION 8.749 • n=7 Participants	69.69 kg STANDARD_DEVIATION 11.861 • n=5 Participants	67.31 kg STANDARD_DEVIATION 9.486 • n=4 Participants	67.94 kg STANDARD_DEVIATION 10.173 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) to Final Visit (Up to Week 12)

Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population.

Outcome measures

Measure	Placebo n=72 Participants Two placebo capsules matching P005672-HCl, taken orally each day	P005672-HCl Approximately 0.75 mg/kg/Day n=76 Participants One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	P005672-HCl Approximately 1.5 mg/kg/Day n=70 Participants Two P005672-HCl 50 mg capsules, taken orally each day	P005672-HCl Approximately 3.0 mg/kg/Day n=66 Participants Two P005672-HCl 100 mg capsules, taken orally each day
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit	12.8 Number of Inflammatory Lesions Standard Deviation 14.18	14.4 Number of Inflammatory Lesions Standard Deviation 13.01	17.6 Number of Inflammatory Lesions Standard Deviation 16.65	17.1 Number of Inflammatory Lesions Standard Deviation 11.69

PRIMARY outcome

Timeframe: Final Visit (Up to Week 12)

Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4.

The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.

Outcome measures

Measure	Placebo n=72 Participants Two placebo capsules matching P005672-HCl, taken orally each day	P005672-HCl Approximately 0.75 mg/kg/Day n=76 Participants One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	P005672-HCl Approximately 1.5 mg/kg/Day n=70 Participants Two P005672-HCl 50 mg capsules, taken orally each day	P005672-HCl Approximately 3.0 mg/kg/Day n=66 Participants Two P005672-HCl 100 mg capsules, taken orally each day
The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit Success	8 Participants	11 Participants	17 Participants	10 Participants
The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit Failure	64 Participants	65 Participants	53 Participants	56 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 12

Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

Outcome measures

Measure	Placebo n=72 Participants Two placebo capsules matching P005672-HCl, taken orally each day	P005672-HCl Approximately 0.75 mg/kg/Day n=76 Participants One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	P005672-HCl Approximately 1.5 mg/kg/Day n=70 Participants Two P005672-HCl 50 mg capsules, taken orally each day	P005672-HCl Approximately 3.0 mg/kg/Day n=66 Participants Two P005672-HCl 100 mg capsules, taken orally each day
The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit Change from Baseline at Week 2	8.4 Count of Inflammatory Lesions Standard Deviation 10.13	8.5 Count of Inflammatory Lesions Standard Deviation 10.02	8.2 Count of Inflammatory Lesions Standard Deviation 14.45	9.7 Count of Inflammatory Lesions Standard Deviation 11.30
The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit Change from Baseline at Week 1	5.8 Count of Inflammatory Lesions Standard Deviation 9.07	5.4 Count of Inflammatory Lesions Standard Deviation 9.28	5.4 Count of Inflammatory Lesions Standard Deviation 8.44	5.9 Count of Inflammatory Lesions Standard Deviation 8.33
The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit Change from Baseline at Week 4	10.9 Count of Inflammatory Lesions Standard Deviation 10.04	9.3 Count of Inflammatory Lesions Standard Deviation 13.84	11.7 Count of Inflammatory Lesions Standard Deviation 15.36	12.8 Count of Inflammatory Lesions Standard Deviation 9.96
The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit Change from Baseline at Week 8	12.6 Count of Inflammatory Lesions Standard Deviation 12.57	13.1 Count of Inflammatory Lesions Standard Deviation 11.89	15.0 Count of Inflammatory Lesions Standard Deviation 16.66	14.3 Count of Inflammatory Lesions Standard Deviation 12.90
The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit Change from Baseline at Week 12	12.8 Count of Inflammatory Lesions Standard Deviation 14.18	14.3 Count of Inflammatory Lesions Standard Deviation 13.00	17.6 Count of Inflammatory Lesions Standard Deviation 16.65	17.1 Count of Inflammatory Lesions Standard Deviation 11.69
The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit Change from Baseline at Final Visit(Up to Week 12)	12.8 Count of Inflammatory Lesions Standard Deviation 14.18	14.4 Count of Inflammatory Lesions Standard Deviation 13.01	17.6 Count of Inflammatory Lesions Standard Deviation 16.65	17.1 Count of Inflammatory Lesions Standard Deviation 11.69

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 12

Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

Outcome measures

Measure	Placebo n=72 Participants Two placebo capsules matching P005672-HCl, taken orally each day	P005672-HCl Approximately 0.75 mg/kg/Day n=76 Participants One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	P005672-HCl Approximately 1.5 mg/kg/Day n=70 Participants Two P005672-HCl 50 mg capsules, taken orally each day	P005672-HCl Approximately 3.0 mg/kg/Day n=66 Participants Two P005672-HCl 100 mg capsules, taken orally each day
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 1	5.4 Count of Noninflammatory Lesions Standard Deviation 12.99	3.8 Count of Noninflammatory Lesions Standard Deviation 14.28	4.3 Count of Noninflammatory Lesions Standard Deviation 14.10	5.1 Count of Noninflammatory Lesions Standard Deviation 13.83
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 2	10.6 Count of Noninflammatory Lesions Standard Deviation 16.02	9.4 Count of Noninflammatory Lesions Standard Deviation 13.58	7.8 Count of Noninflammatory Lesions Standard Deviation 16.92	7.9 Count of Noninflammatory Lesions Standard Deviation 14.24
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 4	13.0 Count of Noninflammatory Lesions Standard Deviation 24.17	10.0 Count of Noninflammatory Lesions Standard Deviation 17.25	9.9 Count of Noninflammatory Lesions Standard Deviation 20.58	12.7 Count of Noninflammatory Lesions Standard Deviation 15.24
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 8	16.9 Count of Noninflammatory Lesions Standard Deviation 22.52	14.3 Count of Noninflammatory Lesions Standard Deviation 21.44	14.0 Count of Noninflammatory Lesions Standard Deviation 22.22	15.2 Count of Noninflammatory Lesions Standard Deviation 19.04
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 12	17.8 Count of Noninflammatory Lesions Standard Deviation 21.63	17.9 Count of Noninflammatory Lesions Standard Deviation 19.85	19.1 Count of Noninflammatory Lesions Standard Deviation 22.33	17.0 Count of Noninflammatory Lesions Standard Deviation 21.56
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Final Visit(Up to Week 12)	17.8 Count of Noninflammatory Lesions Standard Deviation 21.63	17.9 Count of Noninflammatory Lesions Standard Deviation 19.83	19.1 Count of Noninflammatory Lesions Standard Deviation 22.33	17.0 Count of Noninflammatory Lesions Standard Deviation 21.56

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 12

Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

Outcome measures

Measure	Placebo n=72 Participants Two placebo capsules matching P005672-HCl, taken orally each day	P005672-HCl Approximately 0.75 mg/kg/Day n=76 Participants One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	P005672-HCl Approximately 1.5 mg/kg/Day n=70 Participants Two P005672-HCl 50 mg capsules, taken orally each day	P005672-HCl Approximately 3.0 mg/kg/Day n=66 Participants Two P005672-HCl 100 mg capsules, taken orally each day
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 1	19.3 Percent Change - Inflammatory Lesions Standard Deviation 27.82	17.2 Percent Change - Inflammatory Lesions Standard Deviation 28.43	17.8 Percent Change - Inflammatory Lesions Standard Deviation 26.39	19.4 Percent Change - Inflammatory Lesions Standard Deviation 26.17
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 2	25.6 Percent Change - Inflammatory Lesions Standard Deviation 29.02	26.4 Percent Change - Inflammatory Lesions Standard Deviation 32.60	25.8 Percent Change - Inflammatory Lesions Standard Deviation 36.16	30.6 Percent Change - Inflammatory Lesions Standard Deviation 35.88
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 4	34.1 Percent Change - Inflammatory Lesions Standard Deviation 28.84	29.3 Percent Change - Inflammatory Lesions Standard Deviation 38.90	34.1 Percent Change - Inflammatory Lesions Standard Deviation 35.27	40.0 Percent Change - Inflammatory Lesions Standard Deviation 31.83
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 8	37.9 Percent Change - Inflammatory Lesions Standard Deviation 35.60	39.8 Percent Change - Inflammatory Lesions Standard Deviation 34.47	44.3 Percent Change - Inflammatory Lesions Standard Deviation 37.99	44.5 Percent Change - Inflammatory Lesions Standard Deviation 37.62
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 12	39.1 Percent Change - Inflammatory Lesions Standard Deviation 43.00	43.3 Percent Change - Inflammatory Lesions Standard Deviation 39.70	53.6 Percent Change - Inflammatory Lesions Standard Deviation 37.65	53.5 Percent Change - Inflammatory Lesions Standard Deviation 35.18
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Final Visit(Up to Week 12)	39.1 Percent Change - Inflammatory Lesions Standard Deviation 43.00	43.5 Percent Change - Inflammatory Lesions Standard Deviation 39.72	53.6 Percent Change - Inflammatory Lesions Standard Deviation 37.65	53.5 Percent Change - Inflammatory Lesions Standard Deviation 35.18

SECONDARY outcome

Timeframe: Baseline (Week 0) up to Week 12

Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

Outcome measures

Measure	Placebo n=72 Participants Two placebo capsules matching P005672-HCl, taken orally each day	P005672-HCl Approximately 0.75 mg/kg/Day n=76 Participants One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	P005672-HCl Approximately 1.5 mg/kg/Day n=70 Participants Two P005672-HCl 50 mg capsules, taken orally each day	P005672-HCl Approximately 3.0 mg/kg/Day n=66 Participants Two P005672-HCl 100 mg capsules, taken orally each day
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 12	35.3 Percent change - noninflammatory lesions Standard Deviation 35.32	34.3 Percent change - noninflammatory lesions Standard Deviation 36.40	37.2 Percent change - noninflammatory lesions Standard Deviation 38.44	32.8 Percent change - noninflammatory lesions Standard Deviation 42.59
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 1	9.7 Percent change - noninflammatory lesions Standard Deviation 24.07	7.7 Percent change - noninflammatory lesions Standard Deviation 26.87	8.3 Percent change - noninflammatory lesions Standard Deviation 25.20	10.6 Percent change - noninflammatory lesions Standard Deviation 25.63
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 2	19.0 Percent change - noninflammatory lesions Standard Deviation 28.36	16.7 Percent change - noninflammatory lesions Standard Deviation 24.99	14.6 Percent change - noninflammatory lesions Standard Deviation 30.57	16.0 Percent change - noninflammatory lesions Standard Deviation 30.37
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 4	25.0 Percent change - noninflammatory lesions Standard Deviation 37.78	18.3 Percent change - noninflammatory lesions Standard Deviation 33.17	19.2 Percent change - noninflammatory lesions Standard Deviation 35.60	25.7 Percent change - noninflammatory lesions Standard Deviation 29.27
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Week 8	30.5 Percent change - noninflammatory lesions Standard Deviation 40.69	26.1 Percent change - noninflammatory lesions Standard Deviation 38.84	27.5 Percent change - noninflammatory lesions Standard Deviation 38.54	30.4 Percent change - noninflammatory lesions Standard Deviation 38.45
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit Change from Baseline at Final Visit(Up to Week 12)	35.3 Percent change - noninflammatory lesions Standard Deviation 35.32	34.1 Percent change - noninflammatory lesions Standard Deviation 36.28	37.2 Percent change - noninflammatory lesions Standard Deviation 38.44	32.8 Percent change - noninflammatory lesions Standard Deviation 42.59

SECONDARY outcome

Timeframe: Baseline to Final Visit (Up to Week 12)

Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4.

The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.

Outcome measures

Measure	Placebo n=72 Participants Two placebo capsules matching P005672-HCl, taken orally each day	P005672-HCl Approximately 0.75 mg/kg/Day n=76 Participants One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	P005672-HCl Approximately 1.5 mg/kg/Day n=70 Participants Two P005672-HCl 50 mg capsules, taken orally each day	P005672-HCl Approximately 3.0 mg/kg/Day n=66 Participants Two P005672-HCl 100 mg capsules, taken orally each day
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Week 1 · Success	0 Participants	3 Participants	0 Participants	1 Participants
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Final Visit (Up to Week 12) · Failure	64 Participants	65 Participants	53 Participants	56 Participants
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Week 2 · Failure	70 Participants	73 Participants	68 Participants	64 Participants
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Week 1 · Failure	72 Participants	73 Participants	70 Participants	65 Participants
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Week 2 · Success	2 Participants	3 Participants	2 Participants	2 Participants
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Week 4 · Success	1 Participants	2 Participants	0 Participants	4 Participants
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Week 4 · Failure	71 Participants	74 Participants	70 Participants	62 Participants
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Week 8 · Success	6 Participants	6 Participants	8 Participants	11 Participants
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Week 8 · Failure	66 Participants	70 Participants	62 Participants	55 Participants
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Week 12 · Success	8 Participants	11 Participants	17 Participants	10 Participants
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Week 12 · Failure	64 Participants	65 Participants	53 Participants	56 Participants
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 Final Visit (Up to Week 12) · Success	8 Participants	11 Participants	17 Participants	10 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

P005672-HCl Approximately 0.75 mg/kg/Day

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

P005672-HCl Approximately 1.5 mg/kg/Day

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

P005672-HCl Approximately 3.0 mg/kg/Day

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=73 participants at risk Two placebo capsules matching P005672-HCl, taken orally each day	P005672-HCl Approximately 0.75 mg/kg/Day n=76 participants at risk One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	P005672-HCl Approximately 1.5 mg/kg/Day n=70 participants at risk Two P005672-HCl 50 mg capsules, taken orally each day	P005672-HCl Approximately 3.0 mg/kg/Day n=66 participants at risk Two P005672-HCl 100 mg capsules, taken orally each day
Nervous system disorders Headache	11.0% 8/73 • From Screening (up to week -12) to Week 12 plus 30 days.	6.6% 5/76 • From Screening (up to week -12) to Week 12 plus 30 days.	7.1% 5/70 • From Screening (up to week -12) to Week 12 plus 30 days.	6.1% 4/66 • From Screening (up to week -12) to Week 12 plus 30 days.
Gastrointestinal disorders Nausea	5.5% 4/73 • From Screening (up to week -12) to Week 12 plus 30 days.	7.9% 6/76 • From Screening (up to week -12) to Week 12 plus 30 days.	1.4% 1/70 • From Screening (up to week -12) to Week 12 plus 30 days.	3.0% 2/66 • From Screening (up to week -12) to Week 12 plus 30 days.
Infections and infestations Nasopharyngitis	6.8% 5/73 • From Screening (up to week -12) to Week 12 plus 30 days.	5.3% 4/76 • From Screening (up to week -12) to Week 12 plus 30 days.	2.9% 2/70 • From Screening (up to week -12) to Week 12 plus 30 days.	3.0% 2/66 • From Screening (up to week -12) to Week 12 plus 30 days.

Additional Information

Thearpeutic Area Head

Allergan

Phone: 714-246-4500

Email: IR-CTRegistration@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee The data obtained in this study are the property of the Sponsor, any manuscript or other presentation of data must first be reviewed by the Sponsor before its submission.
• Publication restrictions are in place

Restriction type: OTHER