Hidradenitis SuppurativaEarly Phase 1NCT03099980
Exploratory Trial Evaluating Cosentyx (Secukinumab) for Patients With Moderate-to-Severe Hidradenitis Suppurativa
A Early Phase 1 study testing secukinumab in people with Hidradenitis Suppurativa, run by Tufts Medical Center at 1 site in United States.
Trial summary
This is a pilot study in which the the safety and feasibility of secukinumab in HS patients as well as information about the effect size will be determined in order to inform a future larger randomized control trial with an active comparator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2016to Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must give written informed consent before any assessment is performed.
- Subject has moderate-to-severe HS as defined by: 1. HS lesions in at least 2 distinct anatomic areas, one of which is Hurley stage II or III on evaluation at Screening. 2. Stable HS for at least 2 months (60 days) prior to Screening and also at the Baseline visit as determined by the investigator.
- Total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit.
- Subject has had HS diagnosis for at least 3 months prior to Baseline.
- Subject must have failed at least one prior course of oral antibiotics.
- Subject must agree to daily use (and throughout the entirety of the study) of one of the following over-the-counter topical antiseptics on their body areas affected with HS lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach in bathwater.
- Subject must be at least 18 years of age at time of Screening
Who cannot join
- Subject has had history of malignancy within the past 5 years
- Women who are pregnant, nursing, or planning pregnancy within 6 months after last subcutaneous injection. Male patients who are planning for their partner's pregnancies within 6 months from the last subcutaneous injection
- Subject has history of active TB. Subjects with latent TB must have been on treatment for at least 8 weeks prior to Baseline visit and the course of prophylaxis is planned to be completed.
- Subject has had infections requiring oral or intravenous (IV) antibiotics within 14 days prior to Baseline.
- Subject has significant serious medical problems or a condition that significantly immunocompromises the subject.
- Subject has had clinically significant hematological abnormalities defined as HGB <13.5 g/dL (<135 g/L) or a HCT <41.0 percent in men, or a value <12.0 g/dL (<120 g/L) or <36.0 percent in women.
Show all 19Show fewer
- Subject has previously used secukinumab.
- Subject has had any other active skin disease or condition that may interfere with HS assessment.
- Subject has received prescription topical therapies for treatment of HS within 7 days prior to Baseline.
- Subject has received systemic non-biologic therapies with potential therapeutic impact for HS <14 days prior to Baseline visit.
- Clinically significant abnormal laboratory values as evaluated by the investigator.
- Patients with Crohn's disease or Ulcerative Colitis.
- Subject has received any systemic immunosuppressive treatment within 1 month prior to Baseline visit. Subject has received anti-TNF therapy within 3 months prior to Baseline visit. Subject has received anti IL-23 therapy within 3 months prior to Baseline visit.
- Subject has received intralesional steroid injection within 2 weeks prior to Baseline visit.
- Subject with known Human Immunodeficiency Virus (HIV) positive status or with positive HIV testing at Screening.
- Subjects with Hepatitis B and Hepatitis C positive status or with positive Hepatitis B and Hepatitis C testing at screening.
- Subjects with active cardiovascular disease or relevant risk factors such as prior myocardial infection or stroke.
- Subjects with chronic infection or a history of recurrent infections.
- Subjects with a history of latex allergy or sensitivity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center, Department of Dermatology
Boston, Massachusetts, 02111
About this study
Official title: Open-label, Investigator-Initiated, Single Site Exploratory Trial Evaluating Cosentyx (Secukinumab) for Patients With Moderate-to-Severe Hidradenitis Suppurativa
This is a pilot study in which the the safety and feasibility of secukinumab in HS patients as well as information about the effect size will be determined in order to inform a future larger randomized control trial with an active comparator.
Read the detailed description
Secukinumab is an antibody that inhibits Interleukin-17A, and IL-17 promotes neutrophil activities. Neutrophils are found in large numbers in HS. The expression of the inflammatory cytokines IL-17, IL-1β, and TNF-α were enhanced in lesional skin of HS patients.
Prior studies have demonstrated improvement in HS with biologic medications such as the tumor necrosis factor inhibitors adalimumab and infliximab. Studies have shown conflicting data regarding the efficacy of etanercept for HS and success with anakinra.
This is an initial pilot study of secukinumab for the purpose of studying how it may alter HS disease symptoms. This study is not intended to alter indications for drug use but may inform the design of an efficacy study that may alter FDA labeling changes in the future. There are limitations of this study that arise from it being a single-arm clinical trial with a small number of subjects. These limitations include the limited generalizability knowledge of this study due to the lack of an active comparator. However, the data obtained from this study will potentially be used to support the design of larger future randomized placebo controlled studies.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- secukinumab
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secukinumabBiological
Also called Cosentyx
secukinumab 300 mg (2 x 150 mg pre-filled syringe) administered at Baseline, Weeks 1, 2, 3, 4, and then Q4W for 24 weeks via subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Experimental | All participants will be assigned to receive secukinumab 300 mg (2 x 150 mg PFS subcutaneous injections) administered at Baseline, Weeks 1, 2, 3, 4, and then Q4W for 24 more weeks. Receives: Biological: secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hidradenitis Suppurativa Clinical Response (HiSCR)
percent of patients achieving clinical response
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start11 Jul 2016
- Primary completionDec 2018
- Study completionJan 2019
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- secukinumab 300 mg (2 x 150 mg pre-filled syringe) administered at Baseline, Weeks 1, 2, 3, 4, and then Q4W for 24 weeks via subcutaneous injections
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Rosmarin, MD, Principal investigator, Tufts Medical Center, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099980
- Sponsor's protocol ID
- CAIN457AUS03T
- Status last verified
- May 2019
- First submitted
- 29 Mar 2017
- Last updated
- 3 Jun 2019
- 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 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Investigator-Initiated, Single Site Exploratory Trial Evaluating Cosentyx (Secukinumab) for Patients With Moderate-to-Severe Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT03099980
- Acronym / sponsor ID
- CAIN457AUS03T
- Conditions
- Hidradenitis Suppurativa
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 11 Jul 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 4 Apr 2017 (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.
This is a pilot study in which the the safety and feasibility of secukinumab in HS patients as well as information about the effect size will be determined in order to inform a future larger randomized control trial with an active comparator.
Detailed description
Secukinumab is an antibody that inhibits Interleukin-17A, and IL-17 promotes neutrophil activities. Neutrophils are found in large numbers in HS. The expression of the inflammatory cytokines IL-17, IL-1β, and TNF-α were enhanced in lesional skin of HS patients.
Prior studies have demonstrated improvement in HS with biologic medications such as the tumor necrosis factor inhibitors adalimumab and infliximab. Studies have shown conflicting data regarding the efficacy of etanercept for HS and success with anakinra.
This is an initial pilot study of secukinumab for the purpose of studying how it may alter HS disease symptoms. This study is not intended to alter indications for drug use but may inform the design of an efficacy study that may alter FDA labeling changes in the future. There are limitations of this study that arise from it being a single-arm clinical trial with a small number of subjects. These limitations include the limited generalizability knowledge of this study due to the lack of an active comparator. However, the data obtained from this study will potentially be used to support the design of larger future randomized placebo controlled studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- secukinumab 300 mg (2 x 150 mg pre-filled syringe) administered at Baseline, Weeks 1, 2, 3, 4, and then Q4W for 24 weeks via subcutaneous injections
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | Experimental | Biological: secukinumabAll participants will be assigned to receive secukinumab 300 mg (2 x 150 mg PFS subcutaneous injections) administered at Baseline, Weeks 1, 2, 3, 4, and then Q4W for 24 more weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must give written informed consent before any assessment is performed.
- Subject has moderate-to-severe HS as defined by: 1. HS lesions in at least 2 distinct anatomic areas, one of which is Hurley stage II or III on evaluation at Screening. 2. Stable HS for at least 2 months (60 days) prior to Screening and also at the Baseline visit as determined by the investigator.
- Total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit.
- Subject has had HS diagnosis for at least 3 months prior to Baseline.
- Subject must have failed at least one prior course of oral antibiotics.
Key exclusion criteria (19 listed)
- Subject has had history of malignancy within the past 5 years
- Women who are pregnant, nursing, or planning pregnancy within 6 months after last subcutaneous injection. Male patients who are planning for their partner's pregnancies within 6 months from the last subcutaneous injection
- Subject has history of active TB. Subjects with latent TB must have been on treatment for at least 8 weeks prior to Baseline visit and the course of prophylaxis is planned to be completed.
- Subject has had infections requiring oral or intravenous (IV) antibiotics within 14 days prior to Baseline.
- Subject has significant serious medical problems or a condition that significantly immunocompromises the subject.
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 |
|---|---|---|
| secukinumabAlso: Cosentyxsecukinumab 300 mg (2 x 150 mg pre-filled syringe) administered at Baseline, Weeks 1, 2, 3, 4, and then Q4W for 24 weeks via subcutaneous injections | Biological | Secukinumab |
Primary outcome
Hidradenitis Suppurativa Clinical Response (HiSCR)
Time frame: week 24
percent of patients achieving clinical response
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 3 Jun 2019.
- 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.
David Rosmarin, MD principal investigator
Tufts Medical Center, Department of Dermatology
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 secukinumab in people with Hidradenitis Suppurativa, run by Tufts Medical Center 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 7 inclusion and 19 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 3 Jun 2019. 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?
Hidradenitis Suppurativa Clinical Response (HiSCR) (time frame: week 24). 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 3 Jun 2019.