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

• ClinicalTrials.gov Identifier: NCT03079531
• Recruitment Status: Completed
• First Posted: March 14, 2017
• Results First Posted: February 5, 2020
• Last Update Posted: February 5, 2020
• Sponsor: Anne Chang
• Information provided by (Responsible Party): Anne Chang, Stanford University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Papulopustular Rosacea	Drug: Secukinumab	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Secukinumab arm; Participants receive secukinumab (7 doses over a 16-week study period).	Drug: Secukinumab; Secukinumab 300 mg administered subcutaneously.; Other Name: Tremfya

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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).
3. 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).
4. 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.
5. Count of Participants With ≥ Grade 3 Adverse Events [ Time Frame: 16 weeks ]
6. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Stanford Dermatology

Redwood City, California, United States, 94603

Sponsors and Collaborators

Anne Chang

Investigators

• Principal Investigator: Anne Chang, MD; Stanford University

  Study Documents (Full-Text)

Documents provided by Anne Chang, Stanford University:

Study Protocol and Statistical Analysis Plan  [PDF] August 15, 2017

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Anne Chang, Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT03079531
• Other Study ID Numbers: e-protocol 38599
• First Posted: March 14, 2017
• Results First Posted: February 5, 2020
• Last Update Posted: February 5, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Rosacea; Skin Diseases