Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea
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|ClinicalTrials.gov Identifier: NCT03079531|
Recruitment Status : Completed
First Posted : March 14, 2017
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Papulopustular Rosacea||Drug: Secukinumab||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase 1b Study of Secukinumab in Patients With Moderate to Severe Papulopustular Rosacea|
|Actual Study Start Date :||June 21, 2017|
|Actual Primary Completion Date :||January 25, 2019|
|Actual Study Completion Date :||January 25, 2019|
Experimental: Secukinumab arm
Participants receive secukinumab (7 doses over a 16-week study period).
Secukinumab 300 mg administered subcutaneously.
Other Name: Tremfya
- Change From Baseline in Papule/Pustule Count at Week 16 [ Time Frame: Baseline, week 16 ]The total number of papules and pustules on the patient was assessed.
- Change From Baseline Papule/Pustule Count at Week 12 [ Time Frame: Baseline, week 12 ]The total number of papules and pustules on the patient was assessed.
- Change From Baseline in Clinician's Global Severity Score for Rosacea at Week 16 [ Time Frame: Baseline, week 16 ]Scale range: 0-4 (0=none to very mild; 1=mild; 2=moderate; 3=severe; 4=very severe).
- Change From Baseline in Clinician's Global Erythema Assessment Score at Week 16 [ Time Frame: Baseline, week 16 ]Scale range: 0-4 (0=none; 1=mild; 2=moderate; 3=significant; 4=severe).
- Change From Baseline in Rosacea Quality of Life (RosaQoL) Score at Week 16 [ Time Frame: Baseline, week 16 ]Scale range: 0-5 with greater scores denoting worse quality of life.
- Count of Participants With ≥ Grade 3 Adverse Events [ Time Frame: 16 weeks ]
- Change From Baseline in Immune Infiltrates in Papulopustular Rosacea Lesions at Week 16 [ Time Frame: Baseline, 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079531
|United States, California|
|Redwood City, California, United States, 94603|
|Principal Investigator:||Anne Chang, MD||Stanford University|