NCT03079531

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Anne Chang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Papulopustular Rosacea

Interventions

Type	Name	Description
DRUG	Secukinumab	Secukinumab 300 mg administered subcutaneously.

Timeline

• Start date: 2017-06-21
• Primary completion: 2019-01-25
• Completion: 2019-01-25
• First posted: 2017-03-14
• Last updated: 2020-02-05
• Results posted: 2020-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study