| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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
|
Drug: bermekimab
bermekimab 2 mL (200 mg/mL) pre-filled syringe
Drug: placebo placebo 2 mL pre-filled syringe
|
|
Placebo Comparator: placebo ew
2 800 mg placebo loading dose subcutaneous injections, followed by weekly placebo subcutaneous injections
|
Drug: placebo
placebo 2 mL pre-filled syringe
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 33 study locations
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
| Tracking Information | |||||
|---|---|---|---|---|---|
| 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 | ||||
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* 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 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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