Hidradenitis SuppurativaPhase 2NCT03910803
Treatment of Moderate Hidradenitis Suppurativa
A Phase 2 study testing Brodalumab in people with Hidradenitis Suppurativa, run by Florida Academic Dermatology Centers at 1 site in United States.
Trial summary
The study will be conducted over 24 weeks on active therapy followed by a four-week observational visit. The total length of the study will be 28 weeks. Study visits will occur at Screening, Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24 followed by an observational visit. 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?
- Brodalumab
- 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
- 1 May 2019to 1 May 2020
- Phase
- Phase 2
- 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
None listed.
Who cannot join
- Subjects with ANY of the following will be excluded from the study:
- The presence of any of the following will exclude a subject from enrollment:
- Subjects with PGA 4 and 5 , with 15 lesions and significant scarring (defined as any linear, indurated area, extended across more than 50% of the circumference of the affected area) ,fistulas or sinus tract involvement will be excluded.
- Other than Hidradenitis Suppurativa , any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
Show all 31Show fewer
- Women who are pregnant, nursing, or planning pregnancy within 6 months after the last study drug dose (this includes father's who plan on fathering a child within 6 months after their last study drug dose.
- Active substance abuse or a history of substance abuse within 6 months prior to Screening
- Malignancy or history of malignancy, except for: treated [ie, cured] basal cell or squamous cell in situ skin carcinomas; treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
- Active substance abuse or a history of substance abuse within 6 months prior to Screening. .
- Patient with diagnosis or suspected Crohns disease or Ulcerative Colitis.
- Patient who is on a stable dose of analgesics, will be allowed to remain on them. No new opiates will be permitted during the trial.
- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
- Prior treatment with Anti IL-17 drugs ( Secukinumab, ixekizumab and Brodalumab)
- Known allergy to Brodalumab
- Have a known history of serious infections (eg, hepatitis, pneumonia or pyelonephritis) in the previous 3 months
- Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly
- Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
- Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access
- Patient with significant scarring, fistulas, or sinus tract involvement will be excluded. Only subjects with inflammatory abscesses and nodules will be allowed to enter the study.
- Infection(s) requiring treatment with intravenous (IV) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to Baseline or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to Baseline
- Any other active skin disease or condition (e.g., bacterial, fungal or viral infection) that may interfere with assessment of HS;
- History of invasive infection (e.g., listeriosis, histoplasmosis), human immunodeficiency virus (HIV);
- Subject has an active systemic viral infection or any active viral infection that based on the investigator's clinical assessment make the subject an unsuitable candidate for the study;
- Hepatitis B: HBsAg positive (+) or detected sensitivity on the HBV-DNA PCR qualitative test for HBc Ab/HBsAb positive subjects; Or Hepatitis C
- Chronic recurring infections or active TB;
- Evidence of dysplasia
- Pregnant (or considering becoming pregnant) or lactating females.
- The use of any prior biologic therapy is prohibited
- Subjects currently undergoing any of the following treatments for HS will require a 2 week wash-out period: Minocycline; Tetracycline; Clindamycin; Rifampicin and Steroids.
- Presence of active suicidal ideation, or positive suicide behavior using Columbia Suicide Severity Rating Scale (eC-SSRS) and with either of the following criteria: History of a suicide attempt within the 5 years prior to the Screening Visit; Subjects with a history of a suicide attempt more than 5 years ago should be evaluated by a mental healthcare practitioner (HCP) before enrolling into the study. Suicidal ideation in the past month prior to the Screening Visit as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the of the C-SSRS
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134
Fabio A Azevedo, 305-324-2110 ext. 211, fazevedo@fadcenter.com
Martha Gutierrez, 305-324-2110 ext. 210, Mgutierrez@fadcenter.com
About this study
Official title: An Open-label Single Center Study to Evaluate the Efficacy of SILIQ™ (Brodalumab) for the Treatment of Moderate Hidradenitis Suppurativa
The study will be conducted over 24 weeks on active therapy followed by a four-week observational visit. The total length of the study will be 28 weeks.
Study visits will occur at Screening, Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24 followed by an observational visit. Additionally, all subjects will be contacted by phone 1 week following the Baseline visit to ensure daily pain assessments are being recorded. If any signs or symptoms are reported at the time of the call, an unscheduled study visit will be conducted to assess whether an infection is present.
Adverse events will be collected throughout the study.
Read the detailed description
An Open-label Single Center Study to Evaluate the Efficacy of SILIQ™ (brodalumab) for the Treatment of Moderate Hidradenitis Suppurativa. In this Single-Center study a total of 20 subjects will be randomized for a period of 24 weeks of treatment, Followed by an observational four-week post treatment visit. Study visits will occur at Screening , Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28 (4 weeks off therapy). Additionally, all subjects will be contacted by phone 1 week following the Baseline visit to ensure daily pain assessments are being recorded. If any signs or symptoms are reported at the time of the call, an unscheduled study visit will be conducted to assess whether an infection is present.
At Week 4 or Week 8, if PGA is greater or equal to 2 points of baseline, antibiotic rescue is permitted (minocycline or doxycycline up to 100 mg bid).
Safety and efficacy measurements will be performed throughout the study.
The duration of the screening period will be a minimum of 7 days and a maximum of 30 days during which time all of the inclusion and exclusion criteria will be evaluated.
Subjects will have up to 30 days to return to the site for the Baseline visit from the date of the Screening visit.
No study drug will be administered at the final visit.
Subjects may discontinue treatment at any time during study participation. Subjects who prematurely discontinue will be asked to complete a early termination visit.
Subjects who initially screen fail for the study may be permitted to re-screen following re-consent. All screening procedures with the possible exceptions noted below will be repeated. The subject must meet all inclusion and none of the exclusion criteria at the time of re-screening in order to qualify for the study.
The protocol of the study will be approved by the Institutional Review Board (IRB) or the Ethics Committee (EC) of the participating study sites. Depending on the participating countries both local and central IRB/EC approvals will be granted. The study will be registered at www.clinicaltrials.gov before the enrollment of the first patient. The trial will be conducted in compliance with the protocol, GCP, and all applicable regulatory requirements.
Study Endpoints
Primary Endpoint:
The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16, defined as a 50% reduction in the total number of abscess and inflammatory nodule count as long as the fistulae and abcess count remains the same.
Secondary Endpoints:
- The number of patients achieving a one point reduction in PGA score at week 16
- Changes in Modified Sartorius scale from Baseline to Week 16
- The number of patients achieving a two point reduction (required from baseline score) in VAS pain score at week 16
- Dermatology Life Quality Index or DLQI,
- Conditions
- Hidradenitis Suppurativa
- Being tested
- 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
Brodalumab is a human monoclonal IgG2κ antibody directed against human interleukin-17 receptor A (IL-17RA). It is expressed in a Chinese Hamster Ovary (CHO) cell line. Brodalumab is comprised of 1312 amino acids and has an estimated molecular mass of 144,000 Daltons.
Brodalumab Injection is a sterile, preservative-free, yellow solution, delivered via subcutaneous injection. . Each Brodalumab single dose prefilled syringe delivers 1.5 mL of solution containing 210 mg of brodalumab formulated in glutamate (6.5 mg), polysorbate 20 (0.15 mg), proline (36 mg), and Water for Injection, USP at pH 4.8.
| Study group | Role | What they receive |
|---|---|---|
| Brodalumab - Open Label | Other | Randomized subjects will be receiving Brodalumab (210 mg) administered by subcutaneous injection at the following visits: Baseline, week 1, week 2 and every two weeks thereafter, until Week 24.
Investigational Product not to be administer into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by Hidradenitis Suppurativa. Receives: Drug: Brodalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hidradenitis Suppurativa Clinical Response (HiSCR)
Patients at week 16 achieving the Hidradenitis Suppurativa Clinical Response (HiSCR), defined as a ≥ 30% reduction in the total number of abscess and inflammatory nodules, with no increase in the number of abscesses or draining fistulas.
Measured: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Hidradenitis Suppurativa Clinical Response (HiSCR30)
Patients at week 16 achieving the Hidradenitis Suppurativa Clinical Response (HiSCR), defined as a ≥ 30% reduction in the total number of abscess and inflammatory nodules, with no increase in the number of abscesses or draining fistulas. (HiSCR30) when compared with baseline.
Measured: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Hidradenitis Suppurativa Clinical Response (HiSCR50)
Patients achieving a ≥ 30% and ≥ 50% reduction in HiSCR at week 24;
Measured: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Secondary outcomes (4)
Physician s Global Assessment ( PGA)
The PGA score is based on a cumulative global assessment of nodule, abscess, and fistula counts corresponding to a 5-point score (0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe). Efficacy endpoint : the proportions of patients achieving a 1-point reduction in the PGA score.
Measured: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Modified Sartorius
The modified Sartorius score consists of 4 clinical parameters including the number of affected areas and HS lesion hallmarks. It has a minimum value of 0 and no maximum limit.8 Efficacy endpoint :Changes in Modified Sartorius scale from Baseline to Week 16
Measured: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
VAS
Pain will be assessed using a 100-mm VAS (0 = no pain, 100 = maximum pain). The number of patients achieving a two point reduction (required from baseline score) in VAS pain score at week 16
Measured: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Dermatology Life Quality Index or DLQI
It is a validated and widely used questionnaire for assessing Quality of Life related to dermatology conditions. Its score constitutes the summation of responses to all 10 items, ranging from 0 (the best QoL) to 30 (worse QoL).
Measured: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 May 2020 (estimated)
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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Academic Dermatology Centers
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Dermatologics
- Responsible party
- Principal investigator, Francisco A. Kerdel, MD, Florida Academic Dermatology Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910803
- Sponsor's protocol ID
- HS-2018-3620
- Status last verified
- Apr 2019
- First submitted
- 29 Mar 2019
- Last updated
- 10 Apr 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 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Single Center Study to Evaluate the Efficacy of SILIQ™ (Brodalumab) for the Treatment of Moderate Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT03910803
- Acronym / sponsor ID
- HS-2018-3620
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Florida Academic Dermatology CentersUniversity, hospital or other
- Collaborators
- Ortho Dermatologics
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 10 Apr 2019 (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.
The study will be conducted over 24 weeks on active therapy followed by a four-week observational visit. The total length of the study will be 28 weeks.
Study visits will occur at Screening, Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24 followed by an observational visit. Additionally, all subjects will be contacted by phone 1 week following the Baseline visit to ensure daily pain assessments are being recorded. If any signs or symptoms are reported at the time of the call, an unscheduled study visit will be conducted to assess whether an infection is present.
Adverse events will be collected throughout the study.
Detailed description
An Open-label Single Center Study to Evaluate the Efficacy of SILIQ™ (brodalumab) for the Treatment of Moderate Hidradenitis Suppurativa. In this Single-Center study a total of 20 subjects will be randomized for a period of 24 weeks of treatment, Followed by an observational four-week post treatment visit. Study visits will occur at Screening , Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28 (4 weeks off therapy). Additionally, all subjects will be contacted by phone 1 week following the Baseline visit to ensure daily pain assessments are being recorded. If any signs or symptoms are reported at the time of the call, an unscheduled study visit will be conducted to assess whether an infection is present.
At Week 4 or Week 8, if PGA is greater or equal to 2 points of baseline, antibiotic rescue is permitted (minocycline or doxycycline up to 100 mg bid).
Safety and efficacy measurements will be performed throughout the study.
The duration of the screening period will be a minimum of 7 days and a maximum of 30 days during which time all of the inclusion and exclusion criteria will be evaluated.
Subjects will have up to 30 days to return to the site for the Baseline visit from the date of the Screening visit.
No study drug will be administered at the final visit.
Subjects may discontinue treatment at any time during study participation. Subjects who prematurely discontinue will be asked to complete a early termination visit.
Subjects who initially screen fail for the study may be permitted to re-screen following re-consent. All screening procedures with the possible exceptions noted below will be repeated. The subject must meet all inclusion and none of the exclusion criteria at the time of re-screening in order to qualify for the study.
The protocol of the study will be approved by the Institutional Review Board (IRB) or the Ethics Committee (EC) of the participating study sites. Depending on the participating countries both local and central IRB/EC approvals will be granted. The study will be registered at www.clinicaltrials.gov before the enrollment of the first patient. The trial will be conducted in compliance with the protocol, GCP, and all applicable regulatory requirements.
Study Endpoints
Primary Endpoint:
The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at week 16, defined as a 50% reduction in the total number of abscess and inflammatory nodule count as long as the fistulae and abcess count remains the same.
Secondary Endpoints:
- The number of patients achieving a one point reduction in PGA score at week 16
- Changes in Modified Sartorius scale from Baseline to Week 16
- The number of patients achieving a two point reduction (required from baseline score) in VAS pain score at week 16
- Dermatology Life Quality Index or DLQI,
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brodalumab - Open Label | Other | Drug: BrodalumabRandomized subjects will be receiving Brodalumab (210 mg) administered by subcutaneous injection at the following visits: Baseline, week 1, week 2 and every two weeks thereafter, until Week 24. Investigational Product not to be administer into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by Hidradenitis Suppurativa. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (31 listed)
- The presence of any of the following will exclude a subject from enrollment:
- Subjects with PGA 4 and 5 , with 15 lesions and significant scarring (defined as any linear, indurated area, extended across more than 50% of the circumference of the affected area) ,fistulas or sinus tract involvement will be excluded.
- Other than Hidradenitis Suppurativa , any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
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: SiliqBrodalumab is a human monoclonal IgG2κ antibody directed against human interleukin-17 receptor A (IL-17RA). It is expressed in a Chinese Hamster Ovary (CHO) cell line. Brodalumab is comprised of 1312 amino acids and has an estimated molecular mass of 144,000 Daltons. Brodalumab Injection is a sterile, preservative-free, yellow solution, delivered via subcutaneous injection. . Each Brodalumab single dose prefilled syringe delivers 1.5 mL of solution containing 210 mg of brodalumab formulated in glutamate (6.5 mg), polysorbate 20 (0.15 mg), proline (36 mg), and Water for Injection, USP at pH 4.8. | Drug | Brodalumab - Open Label |
Primary outcome
Hidradenitis Suppurativa Clinical Response (HiSCR)
Time frame: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Patients at week 16 achieving the Hidradenitis Suppurativa Clinical Response (HiSCR), defined as a ≥ 30% reduction in the total number of abscess and inflammatory nodules, with no increase in the number of abscesses or draining fistulas.
Hidradenitis Suppurativa Clinical Response (HiSCR30)
Time frame: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Patients at week 16 achieving the Hidradenitis Suppurativa Clinical Response (HiSCR), defined as a ≥ 30% reduction in the total number of abscess and inflammatory nodules, with no increase in the number of abscesses or draining fistulas. (HiSCR30) when compared with baseline.
Hidradenitis Suppurativa Clinical Response (HiSCR50)
Time frame: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Patients achieving a ≥ 30% and ≥ 50% reduction in HiSCR at week 24;
4 secondary outcomes
Physician s Global Assessment ( PGA)
Time frame: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Modified Sartorius
Time frame: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
VAS
Time frame: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Dermatology Life Quality Index or DLQI
Time frame: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brodalumab in people with Hidradenitis Suppurativa, run by Florida Academic Dermatology Centers 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 0 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 10 Apr 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabio A Azevedo (305-324-2110 ext. 211, fazevedo@fadcenter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hidradenitis Suppurativa Clinical Response (HiSCR) (time frame: Study assessments occurr at baseline and at weeks 4, 8, 12, 16, 20, 24, and 28"). 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 10 Apr 2019.