Complement C5a Receptors in Hidradenitis Suppurativa
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ClinicalTrials.gov Identifier: NCT04251663 |
Recruitment Status :
Recruiting
First Posted : February 5, 2020
Last Update Posted : December 13, 2021
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Condition or disease |
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Hidradenitis Suppurativa |

Study Type : | Observational |
Estimated Enrollment : | 40 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Examine the Roles of Complement C5a Receptors in Hidradenitis Suppurativa by ex Vivo Studies |
Actual Study Start Date : | July 18, 2019 |
Estimated Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | June 30, 2022 |

Group/Cohort |
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HS subjects
Subjects with active HS disease, among which at least 5 will be treatment-naïve
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Healthy Controls
Healthy subjects
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- CD11b surface expression on neutrophils [ Time Frame: Day 1 study visit (up to 2 hours) ]Relative expression of adhesion molecule (CD11b) on circulating neutrophils in HS patients determined by flow cytometry.
- C5aR surface expression on neutrophils [ Time Frame: Day 1 study visit (up to 2 hours) ]Relative expression of canonical complement 5a receptor (C5aR) on circulating neutrophils in HS patients determined by flow cytometry.
- Immune cell population profiling [ Time Frame: Day 1 study visit (up to 2 hours) ]Immune cell population profile as measured by the percentage of circulating neutrophils, macrophage and T cells as determined by flow cytometry.
- Measurement of cytokines [ Time Frame: Day 1 study visit (up to 2 hours) ]Skin biopsies will be cultured ex vivo. Cytokine profile as measured by the level of cytokines in assay supernatant by multiplex ELISA: IL-1β, IL-6, TNF-α, IL-12, IL-23, IL-17A, IL-17F, IFN-γ.
- Complement factor analysis [ Time Frame: Day 1 study visit (up to 2 hours) ]Complement factor (such as C1q, C4d, Bb, iC3b, C5b-9) will be analyzed by immunohistochemistry on biopsy samples (pending extra tissue availability after flow cytometry analysis)..

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age 18 or older
- Willing to sign consent and provide a blood sample
- Willing to provide 2 skin biopsies - lesional and perilesional
- Active HS disease or healthy volunteer
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251663
Contact: Clinical Trial Coordinator | 6507217149 | baileyhi@stanford.edu |
United States, California | |
Stanford University | Recruiting |
Redwood City, California, United States, 94063 | |
Contact: Clinical Trial Coordinator 650-721-7149 baileyhi@stanford.edu | |
Sub-Investigator: Aatman Shah |
Principal Investigator: | Kavita Y Sarin, MD PhD | Stanford University |
Responsible Party: | Kavita Sarin, Assistant Professor of Dermatology, Stanford University |
ClinicalTrials.gov Identifier: | NCT04251663 |
Other Study ID Numbers: |
51335 |
First Posted: | February 5, 2020 Key Record Dates |
Last Update Posted: | December 13, 2021 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial |
Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Suppuration |