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

Papulopustular Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079531
• Other study ID #: e-protocol 38599
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 21, 2017
• Est. completion date: January 25, 2019

Study information

• Verified date: January 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• Secukinumab
Secukinumab 300 mg administered subcutaneously.

Locations

Country	Name	City	State
United States	Stanford Dermatology	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Anne Chang

Country where clinical trial is conducted

United States, 

References & Publications (4)

Blauvelt A, Prinz JC, Gottlieb AB, Kingo K, Sofen H, Ruer-Mulard M, Singh V, Pathan R, Papavassilis C, Cooper S; FEATURE Study Group. Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol. 2015 Feb;172(2):484-93. doi: 10.1111/bjd.13348. Epub 2014 Dec 11. — View Citation

Buhl T, Sulk M, Nowak P, Buddenkotte J, McDonald I, Aubert J, Carlavan I, Déret S, Reiniche P, Rivier M, Voegel JJ, Steinhoff M. Molecular and Morphological Characterization of Inflammatory Infiltrate in Rosacea Reveals Activation of Th1/Th17 Pathways. J Invest Dermatol. 2015 Sep;135(9):2198-2208. doi: 10.1038/jid.2015.141. Epub 2015 Apr 7. — View Citation

Chang ALS, Raber I, Xu J, Li R, Spitale R, Chen J, Kiefer AK, Tian C, Eriksson NK, Hinds DA, Tung JY. Assessment of the genetic basis of rosacea by genome-wide association study. J Invest Dermatol. 2015 Jun;135(6):1548-1555. doi: 10.1038/jid.2015.53. Epub 2015 Feb 19. — View Citation

Moustafa F, Hopkinson D, Huang KE, Feldman S. Prevalence of rosacea in community settings. J Cutan Med Surg. 2015 Mar-Apr;19(2):149-52. doi: 10.2310/7750.2014.14087. Epub 2015 Mar 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline Papule/Pustule Count at Week 12	The total number of papules and pustules on the patient was assessed.	Baseline, week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	Count of Participants With = Grade 3 Adverse Events		16 weeks
Secondary	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