Hidradenitis SuppurativaEarly Phase 1NCT04979520
Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa
A Early Phase 1 study testing Brodalumab in people with Hidradenitis Suppurativa and Acne Inversa, run by Rockefeller University at 1 site in United States.
Trial summary
Hidradenitis suppurativa is a disease involving skin folds, causing swelling of the skin and surrounding tissues, pain, and foul-smelling discharges. Effective treatment options are lacking. Recently, clinical trials conducted in our lab found Brodalumab was an effective drug for this disease. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hidradenitis Suppurativa, Acne Inversa
- What is being tested?
- Brodalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2021to 25 Jul 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed clinical diagnosis of Hidradenitis Suppurativa by the Principal Investigator
- Age 18 to 99 years old
- Moderate to severe Hidradenitis Suppurativa with draining tunnels (Hidradenitis Suppurativa Severity Score System/IHS4>4)
- Must have medical insurance that is willing to pay for the study drug throughout the duration of the study
Who cannot join
- Inflammatory Bowel Disease
- HIV Positive
- Active Hepatitis B or C Infection
- Pregnant or Breastfeeding
- No concurrent use of any systemic antibiotics/retinoids/immunosuppressants/biologics (require washout period of >5 half-lives)
- A Score of >10 on the Beck's Depression Inventory (BDI) or on the Patient Health Questionnaire (PHQ)-9
- History of Keloid Scarring
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Official title: A Small Pilot Study to Develop Biomarkers of Weekly Brodalumab Administration in Hidradenitis Suppurativa Patients
Hidradenitis suppurativa is a disease involving skin folds, causing swelling of the skin and surrounding tissues, pain, and foul-smelling discharges. Effective treatment options are lacking. Recently, clinical trials conducted in our lab found Brodalumab was an effective drug for this disease. Weekly dosing achieved superior therapeutic outcomes compared to a dosing given once in every other week. Brodalumab was safe in both regimens, but blood and tissue studies to better understand this response are still needed. By performing this small pilot study and collecting blood and tissue samples from participants treated with Brodalumab once weekly we would like to better characterize the molecular response to this treatment, identify blood and tissue markers reflecting disease severity, and better understand disease mechanisms.
- Conditions
- Hidradenitis Suppurativa, Acne Inversa
- Being tested
- Brodalumab
- Keywords
- Hidradenitis Suppurativa, Acne Inversa, Brodalumab
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrodalumabDrug
Also called Siliq
Subcutaneously Brodalumab/Siliq, 210mg/1.5ml once a week
| Study group | Role | What they receive |
|---|---|---|
| Brodalumab treated moderate-to-severe HS patients | Experimental | Weekly Brodalumab treatment 210mg/1.5ml, given subcutaneously for 12 weeks. Receives: Drug: Brodalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-17 receptor A (IL-17RA) saturation during brodalumab administration at week 12 vs baseline
Percentage change in saturation
Measured: 12 weeks
Secondary outcomes (2)
Change in levels of IL-17A, IL-17C, IL-17, CXCL1, and CXCL8
In Brodalumab treated participants at week 12 compared with baseline
Measured: 12 weeks
Correlate IL-17R saturation (measured by the frequencies of immune cells positive to IL-17RA by flow cytometry) with clinical measures, such as pain or the Hidradenitis Suppurativa Severity Score System (IHS4)
In Brodalumab treated participants at week 12 compared with baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start5 Aug 2021
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yael Renert-Yuval, Rockefeller University
- Investigators
- Yael Renert-Yuval, MD, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979520
- Sponsor's protocol ID
- YYU1014
- Status last verified
- Jul 2022
- First submitted
- 9 Jul 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Small Pilot Study to Develop Biomarkers of Weekly Brodalumab Administration in Hidradenitis Suppurativa Patients
- ClinicalTrials.gov ID
- NCT04979520
- Acronym / sponsor ID
- YYU1014
- Conditions
- Hidradenitis Suppurativa, Acne Inversa
- Keywords
- Hidradenitis Suppurativa, Acne Inversa, Brodalumab
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hidradenitis suppurativa is a disease involving skin folds, causing swelling of the skin and surrounding tissues, pain, and foul-smelling discharges. Effective treatment options are lacking. Recently, clinical trials conducted in our lab found Brodalumab was an effective drug for this disease. Weekly dosing achieved superior therapeutic outcomes compared to a dosing given once in every other week. Brodalumab was safe in both regimens, but blood and tissue studies to better understand this response are still needed. By performing this small pilot study and collecting blood and tissue samples from participants treated with Brodalumab once weekly we would like to better characterize the molecular response to this treatment, identify blood and tissue markers reflecting disease severity, and better understand disease mechanisms.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| Brodalumab treated moderate-to-severe HS patients | Experimental | Drug: BrodalumabWeekly Brodalumab treatment 210mg/1.5ml, given subcutaneously for 12 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed clinical diagnosis of Hidradenitis Suppurativa by the Principal Investigator
- Age 18 to 99 years old
- Moderate to severe Hidradenitis Suppurativa with draining tunnels (Hidradenitis Suppurativa Severity Score System/IHS4>4)
- Must have medical insurance that is willing to pay for the study drug throughout the duration of the study
Key exclusion criteria (8 listed)
- Inflammatory Bowel Disease
- HIV Positive
- Active Hepatitis B or C Infection
- Pregnant or Breastfeeding
- No concurrent use of any systemic antibiotics/retinoids/immunosuppressants/biologics (require washout period of >5 half-lives)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrodalumabAlso: SiliqSubcutaneously Brodalumab/Siliq, 210mg/1.5ml once a week | Drug | Brodalumab treated moderate-to-severe HS patients |
Primary outcome
Interleukin-17 receptor A (IL-17RA) saturation during brodalumab administration at week 12 vs baseline
Time frame: 12 weeks
Percentage change in saturation
2 secondary outcomes
Change in levels of IL-17A, IL-17C, IL-17, CXCL1, and CXCL8
Time frame: 12 weeks
Correlate IL-17R saturation (measured by the frequencies of immune cells positive to IL-17RA by flow cytometry) with clinical measures, such as pain or the Hidradenitis Suppurativa Severity Score System (IHS4)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yael Renert-Yuval, MD principal investigator
The Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Brodalumab in people with Hidradenitis Suppurativa and Acne Inversa, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-17 receptor A (IL-17RA) saturation during brodalumab administration at week 12 vs baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.