Hidradenitis SuppurativaEarly Phase 1NCT04249713
An Alternative Dose Interval Study in Participants With Hidradenitis Suppurativa Receiving Brodalumab
A Early Phase 1 study testing Brodalumab in people with Hidradenitis Suppurativa, run by Rockefeller University at 1 site in United States.
Trial summary
Phase 0 Study of an alternative dosing interval of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa to identify biomarkers of disease activity and clinical response. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hidradenitis Suppurativa
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to Sep 2020
- 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 Diagnosis of Hidradenitis Suppurativa by the PI
- Age 18 or older
- Moderate to Severe Hidradenitis Suppurativa as determined by the PI
- Previously enrolled in JFR-0989
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/imunosuppressants (require washout period of >5 half lives)
- Any medical, psychological or social condition that, in the opinion of the investigator, would jeopardize the health or well being go the participant during any study procedures or the integrity of the data
- High Suicide Risk as determined by the Columbia Suicide Severity Rating Scale
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller University Hospital
New York, New York, 10065
About this study
Official title: An Alternative Dose Interval Study to Examine Safety and Identify Potential Biomarkers in Participants With Hidradenitis Suppurativa Receiving Brodalumab
Phase 0 Study of an alternative dosing interval of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa to identify biomarkers of disease activity and clinical response.
Read the detailed description
Phase 0, Open Label study of an alternative dosing interval of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa. Consisting of n=10 patients receiving 210mg subcutaneously every week for 24 weeks. Patients will be followed for a period of 36 weeks (12 weeks after last dose of Brodalumab) to assess for safety.
- Conditions
- Hidradenitis Suppurativa
- 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
Interleukin 17 Receptor A Antagonist
| Study group | Role | What they receive |
|---|---|---|
| Brodalumab | Experimental | Brodalumab 210mg subcutaneously every week for 24 weeks Receives: Drug: Brodalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers at Week 12
Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL
Measured: Week 12 compared with baseline.
Biomarkers at Week 24
Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL
Measured: Week 24 compared with baseline.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Grade 2/3 adverse events during the study
Measured: Week 0 to Week 24
Secondary outcomes (6)
Clinical Response at Week 12 (as measured by HiSCR)
Clinical Response compared to baseline as assessed by the HiSCR (Hidradenitis Suppurativa Clinical Response) Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas at Week 12 when compared with baseline
Measured: Week 12 compared with Baseline
Clinical Response at Week 12 (as measured by modified Sartorius Score)
Clinical Response compared to baseline as assessed by the modified Sartorius Score as follows: Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is <5 cm; 3 points when it is 5-10 cm; and 9 points when it is >10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is.
Measured: Week 12 compared with Baseline
Clinical Response at Week 12 (as measured by IHS4)
Clinical Response compared to baseline as assessed by IHS4 (International Hidradenitis Suppurativa Severity Score) using the scoring system as follows: Total= (Number of nodules x1) + (Number of abscesses x2) + (Number of draining sinuses/fistulae x4)
Measured: Week 12 compared with Baseline
Clinical Response at Week 24 (as measured by HiSCR)
Clinical Response compared to baseline as assessed by the HiSCR (Hidradenitis Suppurativa Clinical Response) Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas at Week 24 when compared with baseline
Measured: Week 24 compared with Baseline
Clinical Response at Week 24 (as measured by modified Sartorius Score)
Clinical Response compared to baseline as assessed by the modified Sartorius Score as follows: Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is <5 cm; 3 points when it is 5-10 cm; and 9 points when it is >10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is.
Measured: Week 24 compared with Baseline
Clinical Response at Week 24 (as measured by IHS4)
Clinical Response compared to baseline as assessed by IHS4 (International Hidradenitis Suppurativa Severity Score) using the scoring system as follows: Total= (Number of nodules x1) + (Number of abscesses x2) + (Number of draining sinuses/fistulae x4)
Measured: Week 24 compared with Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start3 Feb 2020
- Primary completionJul 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: Biomarker Samples Not Collected
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 Single Arm Study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John W Frew, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249713
- Sponsor's protocol ID
- JFR-0999
- Status last verified
- Sep 2020
- First submitted
- 29 Jan 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Alternative Dose Interval Study to Examine Safety and Identify Potential Biomarkers in Participants With Hidradenitis Suppurativa Receiving Brodalumab
- ClinicalTrials.gov ID
- NCT04249713
- Acronym / sponsor ID
- JFR-0999
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, Acne Inversa, Brodalumab
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Biomarker Samples Not Collected
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 31 Jan 2020 (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.
Phase 0 Study of an alternative dosing interval of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa to identify biomarkers of disease activity and clinical response.
Detailed description
Phase 0, Open Label study of an alternative dosing interval of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa. Consisting of n=10 patients receiving 210mg subcutaneously every week for 24 weeks. Patients will be followed for a period of 36 weeks (12 weeks after last dose of Brodalumab) to assess for safety.
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 Single Arm Study
| Arm | Type | Receives |
|---|---|---|
| Brodalumab | Experimental | Drug: BrodalumabBrodalumab 210mg subcutaneously every week for 24 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 Diagnosis of Hidradenitis Suppurativa by the PI
- Age 18 or older
- Moderate to Severe Hidradenitis Suppurativa as determined by the PI
- Previously enrolled in JFR-0989
Key exclusion criteria (7 listed)
- Inflammatory Bowel Disease
- HIV Positive
- Active Hepatitis B or C Infection
- Pregnant or Breastfeeding
- no concurrent use of any systemic antibiotics/retinoids/imunosuppressants (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: SiliqInterleukin 17 Receptor A Antagonist | Drug | Brodalumab |
Primary outcome
Biomarkers at Week 12
Time frame: Week 12 compared with baseline.
Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL
Biomarkers at Week 24
Time frame: Week 24 compared with baseline.
Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Week 0 to Week 24
Incidence of Grade 2/3 adverse events during the study
6 secondary outcomes
Clinical Response at Week 12 (as measured by HiSCR)
Time frame: Week 12 compared with Baseline
Clinical Response at Week 12 (as measured by modified Sartorius Score)
Time frame: Week 12 compared with Baseline
Clinical Response at Week 12 (as measured by IHS4)
Time frame: Week 12 compared with Baseline
Clinical Response at Week 24 (as measured by HiSCR)
Time frame: Week 24 compared with Baseline
Clinical Response at Week 24 (as measured by modified Sartorius Score)
Time frame: Week 24 compared with Baseline
Clinical Response at Week 24 (as measured by IHS4)
Time frame: Week 24 compared with Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- 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.
John W Frew, MD principal investigator
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, 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 7 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: withdrawn, as of the sponsor's last update on 4 Sep 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Biomarkers at Week 12 (time frame: Week 12 compared with baseline.). The study lists 3 primary outcomes in all. 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 4 Sep 2020.