E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Hidradenitis Suppurativa |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020041 |
E.1.2 | Term | Hidradenitis suppurativa |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the clinical efficacy of bermekimab in participants with moderate to severe HS |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the clinical efficacy of bermekimab in participants with moderate to severe HS. - To characterize additional patient-reported outcome efficacy measures of bermekimab in participants with moderate to severe HS. - To assess the safety and tolerability of bermekimab in participants with moderate to severe HS. - To evaluate the pharmacokinetics (PK) and immunogenicity of bermekimab in participants with moderate to severe HS. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The main protocol includes 2 optional substudies that are planned for EU sites as follows: 1) biomarker substudy 2) pharmacogenomic substudy NOTE: Imaging substudy is for US sites only.
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E.3 | Principal inclusion criteria |
Each potential participant must satisfy all of the following criteria to be enrolled in the study: 1. Be a male or female 18 years of age or older. 2. Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. 3. Have HS for at least 1 year prior to the baseline visit as determined by the investigator through participant interview and/or review of the medical history. 4. Have HS lesions present in at least 2 distinct anatomic areas. 5. Have Hurley Stage II or Hurley Stage III HS as determined by the investigator. |
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E.4 | Principal exclusion criteria |
Any potential participant who meets any of the following criteria will be excluded from participating in the study: 1. Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. 2. Has unstable cardiovascular disease or a cardiac hospitalization within the last 3 months. 3. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly. 4. A history of malignancy within 5 years. 5. Has a history of chronic or recurrent infectious disease, chronic chest infection, recurrent urinary tract infection, fungal infection, or open, draining, or infected skin wounds or ulcers (not related to HS). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Part 1: Week 16 and Part 2: Week 12 |
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E.5.2 | Secondary end point(s) |
1) Proportion of participants achieving HiSCR75 and HiSCR90. 2) Change from baseline in the abscess and inflammatory nodule (AN) count. 3) Proportion of participants achieving at least 50%, 75%, 90%, and 100% reduction in total AN count. 4) Proportion of participants achieving an AN count of 0/1 and 0/1/2. 5) Proportion of participants achieving complete elimination of abscesses among those participants with abscesses. 6) Change in the number of abscesses. 7) Proportion of participants achieving complete elimination of draining fistulas among those participants with draining fistulas at baseline. 8) Change in number of draining fistulas. 9) Proportion of participants achieving complete elimination of inflammatory nodules among those participants with inflammatory nodules. 10) Change in number of inflammatory nodules. 11) Change of International Hidradenitis Suppurativa Severity Score System (IHS4) score. 12) Proportion of participants with HS-Investigator’s Global Assessment (HS-IGA) score of inactive (0), almost inactive (1), or mild (2) and with at least 2-grade improvement. 13) Proportion of participants with HS-IGA score of inactive (0) or almost inactive (1) among participants with HS-IGA score of moderate (3) or severe (4). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Numbers below correspond to section E.5.2. - Part 1 at Week 16 and Part2 at Week 12: 1-5, 7, 9, 13 - Part 1 from baseline to Week 16 and Part 2 at Week 12: 6, 8, 10-12 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
Japan |
United States |
Poland |
Netherlands |
Germany |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 29 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 27 |