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

Study Overview
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Brief Summary
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This is a study to determine whether secukinumab is a potential therapy for those with papulopustular rosacea. We will observe whether this drug decreases the size and/or amount and severity of the pustules of those who suffer from rosacea.

Detailed Description
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Rosacea is a common inflammatory skin disease affecting up to 10% of adults. Despite this, the etiology of rosacea is unclear, although there may be a genetic predisposition (Chang et al., 2015). Currently, there is no cure. Rosacea can lead to scarring, itching, burning, and is associated with anxiety and depression (Moustafa et al., 2015), significantly affecting quality of life. Secukinumab is an antibody that binds to a protein (interleukin (IL)-17A) that is involved in inflammation. When IL-17A is bound to secukinumab, it cannot bind to its receptor, thereby inhibiting its ability to feed the inflammatory response. In clinical trials, secukinumab has been effective for moderate to severe psoriasis (Blauvelt et al., 2015). Recently, human data from all types of rosacea have shown Th1/Th17 polarization profile of the T-cell response, suggesting that anti-IL-17 therapy may be beneficial for rosacea (Buhl et al., 2015). Hence, secukinumab could be effective against rosacea. This proposal is a proof-of-concept study to use secukinumab in open label design for moderate to severe papulopustular rosacea.

Official Title
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An Open Label Phase 1b Study of Secukinumab in Patients With Moderate to Severe Papulopustular Rosacea

Conditions
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Papulopustular Rosacea

Intervention / Treatment
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* Drug: Secukinumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate to severe papulopustular rosacea defined clinically using the grading system of Wilkin et al. (2004) as having at least ten lesions (either papules or pustules) on face at time of enrollment age 18 years or greater willing and able to understand and sign informed consent form Exclusion Criteria: known hypersensitivity to secukinumab topical or oral anti-rosacea medication usage for 28 days prior to enrollment active Crohn's disease, as secukinumab may exacerbate this disease active infection including tuberculosis, hepatitis B or C, human immunodeficiency virus participants with latent tuberculosis will need to have treatment initiated prior to starting study drug pregnant or lactating active and/or uncontrolled medical conditions that may interfere with study procedures or obscure rosacea assessment such as cutaneous lupus use of retinoids within past 3 months of enrollment use of antibiotics within 4 weeks of enrollment use of light based or laser treatment to face within 8 weeks of enrollment use of topical or systemic steroids within 4 weeks of enrollment acne conglobate, acne fulminans, chloracne, severe acne requiring systemic treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secukinumab arm<br>Participants receive secukinumab (7 doses over a 16-week study period). | Drug: Secukinumab<br>* Secukinumab 300 mg administered subcutaneously.<br>* Other names: Tremfya;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Papule/Pustule Count at Week 16 | The total number of papules and pustules on the patient was assessed. | Baseline, week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Papule/Pustule Count at Week 12 | The total number of papules and pustules on the patient was assessed. | Baseline, week 12 | 
| Change From Baseline in Clinician's Global Severity Score for Rosacea at Week 16 | Scale range: 0-4 (0=none to very mild; 1=mild; 2=moderate; 3=severe; 4=very severe). | Baseline, week 16 | 
| Change From Baseline in Clinician's Global Erythema Assessment Score at Week 16 | Scale range: 0-4 (0=none; 1=mild; 2=moderate; 3=significant; 4=severe). | Baseline, week 16 | 
| Change From Baseline in Rosacea Quality of Life (RosaQoL) Score at Week 16 | Scale range: 0-5 with greater scores denoting worse quality of life. | Baseline, week 16 | 
| Count of Participants With ≥ Grade 3 Adverse Events |  | 16 weeks | 
| Change From Baseline in Immune Infiltrates in Papulopustular Rosacea Lesions at Week 16 | 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). | Baseline, week 16 |