Trial Outcomes & Findings for A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris (NCT NCT03127956)

NCT ID: NCT03127956

Last Updated: 2021-07-20

Results Overview

Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 748 participants
• Primary outcome timeframe: Day 1 - Week 36
• Results posted on: 2021-07-20

Participant Flow

Participant milestones

Measure	Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
Overall Study STARTED	748
Overall Study COMPLETED	431
Overall Study NOT COMPLETED	317

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Baseline characteristics by cohort

Measure	Olumacostat Glasaretil Gel, 5.0% n=741 Participants Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
Age, Categorical <=18 years	446 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	295 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	19.3 Years STANDARD_DEVIATION 7.04 • n=5 Participants
Sex: Female, Male Female	423 Participants n=5 Participants
Sex: Female, Male Male	318 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	211 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	522 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	133 Participants n=5 Participants
Race (NIH/OMB) White	546 Participants n=5 Participants
Race (NIH/OMB) More than one race	29 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	30 participants n=5 Participants
Region of Enrollment United States	625 participants n=5 Participants
Region of Enrollment Australia	86 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 - Week 36

Population: Safety Population

Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions

Outcome measures

Measure	Olumacostat Glasaretil Gel, 5.0% n=741 Participants Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Adverse Events (Mild)	197 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Adverse Events (Moderate)	124 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Adverse Events (Severe)	18 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Adverse Events (Not Reported)	402 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Burning/Stinging (None)	518 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Burning/Stinging (Mild)	11 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Burning/Stinging (Moderate)	2 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Burning/Stinging (Severe)	0 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Burning/Stinging (Not Reported)	210 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Pruritus (None)	500 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Pruritus (Mild)	29 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Pruritus (Moderate)	2 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Pruritus (Severe)	0 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Pruritus (Not Reported)	210 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Erythema (None)	469 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Erythema (Mild)	55 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Erythema (Moderate)	7 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Erythema (Severe)	0 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Erythema (Not Reported)	210 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Dryness (None)	485 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Dryness (Mild)	43 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Dryness (Moderate)	3 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Dryness (Severe)	0 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Dryness (Not Reported)	210 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Peeling (None)	507 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Peeling (Mild)	22 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Peeling (Moderate)	1 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Peeling (Severe)	0 Participants
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Peeling (Not Reported)	211 Participants

Adverse Events

Olumacostat Glasaretil Gel, 5.0%

Serious events: 8 serious events

Other events: 281 other events

Deaths: 0 deaths

Serious adverse events

Measure	Olumacostat Glasaretil Gel, 5.0% n=741 participants at risk Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
Infections and infestations Infectious mononucleosis	0.13% 1/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Infections and infestations Urinary tract infection	0.13% 1/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Injury, poisoning and procedural complications Ankle fracture	0.13% 1/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Nervous system disorders Epilepsy	0.13% 1/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Psychiatric disorders Depression	0.13% 1/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Psychiatric disorders Suicidal ideation	0.13% 1/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.13% 1/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Vascular disorders Hypertension	0.13% 1/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.

Other adverse events

Measure	Olumacostat Glasaretil Gel, 5.0% n=741 participants at risk Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
General disorders Application site dryness	3.8% 28/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
General disorders Application site erythema	3.4% 25/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
General disorders Application site pain	3.9% 29/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
General disorders Application site pruritus	5.3% 39/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Infections and infestations Influenza	2.2% 16/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Infections and infestations Nasopharyngitis	6.6% 49/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Infections and infestations Upper respiratory tract infection	7.7% 57/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Injury, poisoning and procedural complications Sunburn	2.6% 19/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Nervous system disorders Headache	2.6% 19/741 • Baseline to Week 36 The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

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