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

Primary Purpose

Papulopustular Rosacea

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Secukinumab

About this trial

This is an interventional treatment trial for Papulopustular Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Secukinumab arm

Arm Description

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

Outcomes

Primary Outcome Measures

Change From Baseline in Papule/Pustule Count at Week 16

The total number of papules and pustules on the patient was assessed.

Secondary Outcome Measures

Change From Baseline Papule/Pustule Count at 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

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

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

Scale range: 0-5 with greater scores denoting worse quality of life.

Count of Participants With ≥ Grade 3 Adverse Events

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).

Full Information

NCT ID

NCT03079531

First Posted

March 9, 2017

Last Updated

January 17, 2020

Sponsor

Anne Chang

1. Study Identification

Unique Protocol Identification Number

NCT03079531

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

June 21, 2017 (Actual)

Primary Completion Date

January 25, 2019 (Actual)

Study Completion Date

January 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Anne Chang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Papulopustular Rosacea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Secukinumab arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Secukinumab

Other Intervention Name(s)

Tremfya

Intervention Description

Secukinumab 300 mg administered subcutaneously.

Primary Outcome Measure Information:

Title

Change From Baseline in Papule/Pustule Count at Week 16

Description

The total number of papules and pustules on the patient was assessed.

Time Frame

Baseline, week 16

Secondary Outcome Measure Information:

Title

Change From Baseline Papule/Pustule Count at Week 12

Description

The total number of papules and pustules on the patient was assessed.

Time Frame

Baseline, week 12

Title

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

Description

Scale range: 0-4 (0=none to very mild; 1=mild; 2=moderate; 3=severe; 4=very severe).

Time Frame

Baseline, week 16

Title

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

Description

Scale range: 0-4 (0=none; 1=mild; 2=moderate; 3=significant; 4=severe).

Time Frame

Baseline, week 16

Title

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

Description

Scale range: 0-5 with greater scores denoting worse quality of life.

Time Frame

Baseline, week 16

Title

Count of Participants With ≥ Grade 3 Adverse Events

Time Frame

16 weeks

Title

Change From Baseline in Immune Infiltrates in Papulopustular Rosacea Lesions at Week 16

Description

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).

Time Frame

Baseline, week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Chang, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford Dermatology

City

Redwood City

State/Province

California

ZIP/Postal Code

94603

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25695682

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.

Results Reference

background

PubMed Identifier

25775639

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.

Results Reference

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PubMed Identifier

25132411

Citation

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.

Results Reference

background

PubMed Identifier

25848978

Citation

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.

Results Reference

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

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