Condition or disease | Intervention/treatment | Phase |
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Hidradenitis Suppurativa Acne Inversa Suppurative Hidradenitis | Drug: bermekimab Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 144 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patients will be randomized to every week bermekimab injections, every other week bermekimab injections, or every week placebo injections. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Bermekimab in Patients With Moderate to Severe Hidradenitis Suppurativa |
Actual Study Start Date : | September 16, 2019 |
Actual Primary Completion Date : | May 19, 2020 |
Actual Study Completion Date : | November 17, 2020 |
Arm | Intervention/treatment |
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Experimental: bermekimab ew
2 800 mg bermekimab loading dose subcutaneous injections, followed by weekly 400 mg bermekimab injections
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Drug: bermekimab
bermekimab 2 mL (200 mg/mL) pre-filled syringe
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Experimental: bermekimab eow
2 800 mg loading dose subcutaneous injections, followed by alternating weekly 400 mg bermekimab injections with matching placebo injections
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Drug: bermekimab
bermekimab 2 mL (200 mg/mL) pre-filled syringe
Drug: placebo placebo 2 mL pre-filled syringe
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Placebo Comparator: placebo ew
2 800 mg placebo loading dose subcutaneous injections, followed by weekly placebo subcutaneous injections
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Drug: placebo
placebo 2 mL pre-filled syringe
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Tracking Information | |||||
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First Submitted Date ICMJE | July 9, 2019 | ||||
First Posted Date ICMJE | July 15, 2019 | ||||
Last Update Posted Date | May 25, 2021 | ||||
Actual Study Start Date ICMJE | September 16, 2019 | ||||
Actual Primary Completion Date | May 19, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: Week 12 ] HiSCR is defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa | ||||
Official Title ICMJE | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Bermekimab in Patients With Moderate to Severe Hidradenitis Suppurativa | ||||
Brief Summary | This study further evaluates the efficacy of bermekimab in treating moderate to severe hidradenitis suppurativa in adults. 1/3 of patients will receive weekly injections of bermekimab, 1/3 will receive alternating every other week injections of bermekimab or placebo, and 1/3 will receive weekly injections of placebo. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Patients will be randomized to every week bermekimab injections, every other week bermekimab injections, or every week placebo injections. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
144 | ||||
Original Estimated Enrollment ICMJE |
150 | ||||
Actual Study Completion Date ICMJE | November 17, 2020 | ||||
Actual Primary Completion Date | May 19, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04019041 | ||||
Other Study ID Numbers ICMJE | CR108834 77474462HDS2002 ( Other Identifier: Janssen Research & Development, LLC ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Janssen Research & Development, LLC | ||||
Study Sponsor ICMJE | Janssen Research & Development, LLC | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Janssen Research & Development, LLC | ||||
Verification Date | March 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |