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

NCT03079531 | Completed Phase 1 Results FDA Drug

• 1 other identifier: e-protocol 38599
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Papulopustular Rosacea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change From Baseline Papule/Pustule Count at Week 12

  Baseline, week 12

• Change From Baseline in Clinician's Global Severity Score for Rosacea at Week 16

  Baseline, week 16

• Change From Baseline in Clinician's Global Erythema Assessment Score at Week 16

  Baseline, week 16

• Change From Baseline in Rosacea Quality of Life (RosaQoL) Score at Week 16

  Baseline, week 16

• Count of Participants With ≥ Grade 3 Adverse Events

  16 weeks

Study Arms (1)

Secukinumab arm

EXPERIMENTAL

Participants receive secukinumab (7 doses over a 16-week study period).

Drug: Secukinumab

Interventions

Secukinumab DRUG

Secukinumab 300 mg administered subcutaneously.

Also known as: Tremfya

Secukinumab arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anne Chang: lead

Study Sites (1)

Stanford Dermatology

Redwood City, California, 94603, United States

Location

Related Publications (4)

• 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.

  PMID: 25695682 BACKGROUND

• 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.

  PMID: 25775639 BACKGROUND

• 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.

  PMID: 25132411 BACKGROUND

• Buhl T, Sulk M, Nowak P, Buddenkotte J, McDonald I, Aubert J, Carlavan I, Deret 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.

  PMID: 25848978 BACKGROUND

MeSH Terms

Conditions

Rosacea

Interventions

secukinumab; guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Anne Lynn Chang, MD
• Organization: Stanford University

alschang@stanford.edu

650-723-6316

Study Officials

• Anne Chang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 14, 2017
• Study Start: June 21, 2017
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)