NCT04251663

Brief Summary

To study the role of C5a in Hidradenitis Suppurativa (HS). Complement C5a is a major chemotactic factor that stimulates neutrophil infiltration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 18, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2022

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

3 years

First QC Date

July 18, 2019

Last Update Submit

June 22, 2023

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (2)

  • CD11b surface expression on neutrophils

    Relative expression of adhesion molecule (CD11b) on circulating neutrophils in HS patients determined by flow cytometry.

    Day 1 study visit (up to 2 hours)

  • C5aR surface expression on neutrophils

    Relative expression of canonical complement 5a receptor (C5aR) on circulating neutrophils in HS patients determined by flow cytometry.

    Day 1 study visit (up to 2 hours)

Secondary Outcomes (2)

  • Immune cell population profiling

    Day 1 study visit (up to 2 hours)

  • Measurement of cytokines

    Day 1 study visit (up to 2 hours)

Other Outcomes (1)

  • Complement factor analysis

    Day 1 study visit (up to 2 hours)

Study Arms (2)

HS subjects

Subjects with active HS disease, among which at least 5 will be treatment-naïve

Healthy Controls

Healthy subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The team will collect plasma and tissue samples from 40 HS patients with active disease, among which at least 5 will be treatment-naïve. Plasma from 10 healthy volunteers will be used as controls. The team will try to obtain blood and 2 skin biopsies (1 from a HS lesion, 1 from normal skin).

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Study Officials

  • Kavita Y Sarin, MD PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Dermatology

Study Record Dates

First Submitted

July 18, 2019

First Posted

February 5, 2020

Study Start

July 18, 2019

Primary Completion

July 29, 2022

Study Completion

July 29, 2022

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)