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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab arm | Experimental | Participants receive secukinumab (7 doses over a 16-week study period). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | Secukinumab 300 mg administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Papule/Pustule Count at Week 12 | The total number of papules and pustules on the patient was assessed. | Baseline, week 12 |
| Change From Baseline in Clinician's Global Severity Score for Rosacea at Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Chang, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Dermatology | Redwood City | California | 94603 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25695682 | Background | 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. | |
| 25775639 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab Arm | Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants with at least one post-baseline visit were considered evaluable in this trial, and are included in the analysis for Baseline Characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab Arm | Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Papule/Pustule Count at Week 16 | The total number of papules and pustules on the patient was assessed. | Participants who completed through week 16 are included in the analysis. | Posted | Median | Inter-Quartile Range | papules and pustules | Baseline, week 16 |
|
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Secukinumab Arm | Secukinumab 300 mg administered subcutaneously (7 doses over a 16-week study period). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin or nail infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Lynn Chang, MD | Stanford University | 650-723-6316 | alschang@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2017 | Jan 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
| C000588857 | guselkumab |
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Scale range: 0-4 (0=none to very mild; 1=mild; 2=moderate; 3=severe; 4=very severe).
| Baseline, week 16 |
| 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 |
| 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 |
| Count of Participants With ≥ Grade 3 Adverse Events | 16 weeks |
| 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 |
| 25132411 | 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. |
| 25848978 | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Papule/pustule count | The total number of papules and pustules on the patient was assessed. | Median | Inter-Quartile Range | papules and pustules |
|
| Clinician's Global Severity Score for Rosacea | Scale range: 0-4 (0=none to very mild; 1=mild; 2=moderate; 3=severe; 4=very severe). | Median | Inter-Quartile Range | score on a scale |
|
| Clinician's Global Erythema Assessment Score | Scale range: 0-4 (0=none; 1=mild; 2=moderate; 3=significant; 4=severe). | Median | Inter-Quartile Range | score on a scale |
|
| Rosacea Quality of Life (RosaQoL) Score | Scale range: 0-5 with greater scores denoting worse quality of life. | Median | Inter-Quartile Range | score on a scale |
|
| Immune Infiltrates in Papulopustular Rosacea Lesions | 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). | Median | Inter-Quartile Range | score on a scale |
|
|
|
| Secondary | Change From Baseline Papule/Pustule Count at Week 12 | The total number of papules and pustules on the patient was assessed. | Participants who completed through week 12 are included in the analysis. | Posted | Median | Inter-Quartile Range | papules and pustules | 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). | Participants who completed through week 16 are included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | 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). | Participants who completed through week 16 are included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | 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. | Participants who completed through week 16 are included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, week 16 |
|
|
|
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| Secondary | Count of Participants With ≥ Grade 3 Adverse Events | Posted | Count of Participants | Participants | 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). | Participants who contributed skin biopsies at both week 0 and week 16 are included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, week 16 |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 11 |
| 24 |
| Otitis externa | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinus pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinus disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Flu like symptoma | General disorders | Systematic Assessment |
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| Injection site reaction | General disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash (eczema) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Hearing impaired | Ear and labyrinth disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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