Trial Outcomes & Findings for Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea (NCT NCT03079531)

NCT ID: NCT03079531

Last Updated: 2020-02-05

Results Overview

The total number of papules and pustules on the patient was assessed.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Baseline, week 16
• Results posted on: 2020-02-05

Participant Flow

Participant milestones

Measure	Secukinumab Arm Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
Overall Study STARTED	24
Overall Study Attended ≥1 Post-baseline Visit	23
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea

Baseline characteristics by cohort

Measure	Secukinumab Arm n=23 Participants Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race/Ethnicity, Customized White	18 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Two or More Races	1 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants
Papule/pustule count	13.00 papules and pustules n=5 Participants
Clinician's Global Severity Score for Rosacea	1.83 score on a scale n=5 Participants
Clinician's Global Erythema Assessment Score	1.67 score on a scale n=5 Participants
Rosacea Quality of Life (RosaQoL) Score	3.48 score on a scale n=5 Participants
Immune Infiltrates in Papulopustular Rosacea Lesions	2.50 score on a scale n=5 Participants

PRIMARY outcome

Timeframe: Baseline, week 16

Population: Participants who completed through week 16 are included in the analysis.

The total number of papules and pustules on the patient was assessed.

Outcome measures

Measure	Secukinumab Arm n=17 Participants Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
Change From Baseline in Papule/Pustule Count at Week 16	-5.00 papules and pustules Interval -17.6 to 1.0

SECONDARY outcome

Timeframe: Baseline, week 12

Population: Participants who completed through week 12 are included in the analysis.

The total number of papules and pustules on the patient was assessed.

Outcome measures

Measure	Secukinumab Arm n=17 Participants Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
Change From Baseline Papule/Pustule Count at Week 12	-7.00 papules and pustules Interval -16.66 to 0.0

SECONDARY outcome

Timeframe: Baseline, week 16

Population: Participants who completed through week 16 are included in the analysis.

Scale range: 0-4 (0=none to very mild; 1=mild; 2=moderate; 3=severe; 4=very severe).

Outcome measures

Measure	Secukinumab Arm n=17 Participants Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
Change From Baseline in Clinician's Global Severity Score for Rosacea at Week 16	-0.33 score on a scale Interval -0.83 to 0.17

SECONDARY outcome

Timeframe: Baseline, week 16

Population: Participants who completed through week 16 are included in the analysis.

Scale range: 0-4 (0=none; 1=mild; 2=moderate; 3=significant; 4=severe).

Outcome measures

Measure	Secukinumab Arm n=17 Participants Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
Change From Baseline in Clinician's Global Erythema Assessment Score at Week 16	-0.33 score on a scale Interval -0.83 to 0.17

SECONDARY outcome

Timeframe: Baseline, week 16

Population: Participants who completed through week 16 are included in the analysis.

Scale range: 0-5 with greater scores denoting worse quality of life.

Outcome measures

Measure	Secukinumab Arm n=17 Participants Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
Change From Baseline in Rosacea Quality of Life (RosaQoL) Score at Week 16	-0.61 score on a scale Interval -1.53 to -0.14

SECONDARY outcome

Timeframe: 16 weeks

Outcome measures

Measure	Secukinumab Arm n=24 Participants Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
Count of Participants With ≥ Grade 3 Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Baseline, week 16

Population: Participants who contributed skin biopsies at both week 0 and week 16 are included in the analysis.

Immune infiltrates as assessed by immunohistochemistry, using a semi-quantitative grading scale for histological inflammation (scale range: 0-4, with 0-normal to 4-widespread inflammation).

Outcome measures

Measure	Secukinumab Arm n=7 Participants Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
Change From Baseline in Immune Infiltrates in Papulopustular Rosacea Lesions at Week 16	0.43 score on a scale Interval -0.25 to 1.5

Adverse Events

Secukinumab Arm

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Secukinumab Arm n=24 participants at risk Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period).
Infections and infestations Skin or nail infection	16.7% 4/24 • 16 weeks
Infections and infestations Otitis externa	4.2% 1/24 • 16 weeks
Infections and infestations Sinusitis	4.2% 1/24 • 16 weeks
Infections and infestations Urinary tract infection	4.2% 1/24 • 16 weeks
Infections and infestations Gastrointestinal infection	4.2% 1/24 • 16 weeks
Infections and infestations Upper respiratory infection	4.2% 1/24 • 16 weeks
Respiratory, thoracic and mediastinal disorders Sore throat	8.3% 2/24 • 16 weeks
Respiratory, thoracic and mediastinal disorders Cough	4.2% 1/24 • 16 weeks
Respiratory, thoracic and mediastinal disorders Sinus pain	4.2% 1/24 • 16 weeks
Respiratory, thoracic and mediastinal disorders Sinus disorder	4.2% 1/24 • 16 weeks
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	4.2% 1/24 • 16 weeks
General disorders Fatigue	12.5% 3/24 • 16 weeks
General disorders Flu like symptoma	4.2% 1/24 • 16 weeks
General disorders Injection site reaction	4.2% 1/24 • 16 weeks
Skin and subcutaneous tissue disorders Pruritus	12.5% 3/24 • 16 weeks
Skin and subcutaneous tissue disorders Rash (eczema)	8.3% 2/24 • 16 weeks
Gastrointestinal disorders Diarrhea	12.5% 3/24 • 16 weeks
Gastrointestinal disorders Vomiting	4.2% 1/24 • 16 weeks
Ear and labyrinth disorders Hearing impaired	4.2% 1/24 • 16 weeks
Renal and urinary disorders Dysuria	4.2% 1/24 • 16 weeks
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 1/24 • 16 weeks

Additional Information

Anne Lynn Chang, MD

Stanford University

Phone: 650-723-6316

Email: alschang@stanford.edu

Results disclosure agreements

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