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JRCT ID: jRCT2031210308

Registered date:13/09/2021

A Study of Bermekimab for the Treatment of Participants with Moderate to Severe Hidradenitis Suppurativa

Basic Information

Recruitment status	Complete
Health condition(s) or Problem(s) studied	Hidradenitis Suppurativa
Date of first enrollment	13/01/2022
Target sample size	300
Countries of recruitment	Germany,Japan,Netherlands,Japan,United States of America,Japan,Australia,Japan,Canada,Japan,Poland,Japan,Spain,Japan
Study type	Interventional
Intervention(s)	Bermekimab Bermekimab will be administered subcutaneously. Part 1 (Group1): Placebo Part 1 (Group 3):Bermekimab Dose 1 Part 2 (Group 1):Placebo Part 2 (Group 2):Bermekimab Dose 1 Part 2 (Group 3):Bermekimab Dose 1 Part 2 (Group 4):Bermekimab Dose 2 Adalimumab Adalimumab will be administered subcutaneously. Part 1 (Group 2):Adalimumab Placebo Placebo will be administered subcutaneously. Part 1 (Group1): Placebo Part 1 (Group 2):Adalimumab Part 1 (Group 3):Bermekimab Dose 1 Part 2 (Group 1):Placebo Part 2 (Group 3):Bermekimab Dose 1 Part 2 (Group 4):Bermekimab Dose 2

TO Original Data: JRCT

Outcome(s)

Primary Outcome	-Part 1: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 HiSCR50 is defined as at least a 50 percent reduction from baseline in the total abscess and inflammatory nodule (AN) count with no increase in abscess or draining fistula count. Percentage of participants achieving HisCR50 will be reported. -Part 2: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 12 HiSCR50 is defined as at least a 50 percent reduction from baseline in the total AN count with no increase in abscess or draining fistula count. Percentage of participants achieving HisCR50 will be reported.
Secondary Outcome	-Part 1 and Part 2: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-75 (HiSCR75) Part 1: Week 16; Part 2: Week 12 HiSCR75 is defined as at least a 75 percent reduction from baseline in the total AN count with no increase in abscess or draining fistula count. Percentage of participants achieving HiSCR75 will be reported. -Part 1 and Part 2: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-90 (HiSCR90) Part 1: Week 16; Part 2: Week 12 HiSCR90 is defined as at least a 90 percent reduction from baseline in the total AN count with no increase in abscess or draining fistula count. Percentage of participants achieving HiSCR90 will be reported. Parts 1 and 2: Change from Baseline in the (AN) Count Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in the AN count will be reported. -Parts 1 and 2: Percentage of Participants Achieving at Least 50 percent, 75 percent, 90 percent, and 100 percent Reduction in Total AN Count Part 1: Week 16; Part 2: Week 12 Percentage of participants achieving at least 50 percent, 75 percent, 90 percent, and 100 percent reduction in total AN count will be reported. -Parts 1 and 2: Percentage of Participants Achieving an AN Count of 0/1 and 0/1/2 Part 1: Week 16; Part 2: Week 12 Percentage of participants achieving an AN count of 0/1 and 0/1/2 will be reported. -Parts 1 and 2: Percentage of Participants Achieving Complete Elimination of Abscesses Among those Participants with Abscesses at Baseline Part 1: Week 16; Part 2: Week 12 Percentage of participants achieving complete elimination of abscesses among those participants with abscesses at baseline will be reported. -Parts 1 and 2: Change from Baseline in the Number of Abscesses Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in the number of abscesses will be reported. -Parts 1 and 2: Percentage of Participants Achieving Complete Elimination of Draining Fistulas Among those Participants with Draining Fistulas at Baseline Part 1: Week 16; Part 2: Week 12 Percentage of participants achieving complete elimination of abscesses among those participants with abscesses at baseline will be reported. -Parts 1 and 2: Change from Baseline in Number of Draining Fistulas Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in number of draining fistulas will be reported. - Parts 1 and 2: Percentage of Participants Achieving Complete Elimination of Inflammatory Nodules Among those Participants with Inflammatory Nodules at Baseline Part 1: Week 16; Part 2: Week 12 Percentage of participants achieving complete elimination of inflammatory nodules among those participants with inflammatory nodules at baseline will be reported. -Parts 1 and 2: Change from Baseline in Number of Inflammatory Nodules Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in number of inflammatory nodules will be reported. -Parts 1 and 2: Change from Baseline in International Hidradenitis Suppurativa Severity (IHS4) Score Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in IHS4 score will be reported. The IHS4 assesses the Hidradenitis Suppurativa (HS) severity and the resulting IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. -Parts 1 and 2: Percentage of Participants with Hidradenitis Suppurativa-Investigato's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild (2) and with at least 2-grade Part 1: Week 16; Part 2: Week 12 Percentage of participants with HS-IGA score of inactive (0), almost inactive (1), or mild (2) and with at least 2-grade improvement relative to baseline will be reported. The participant's HS is assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. -Parts 1 and 2: Percentage 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) at Baseline Part 1: Week 16; Part 2: Week 12 Percentage 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) at baseline will be reported. -Parts 1 and 2: Change from Baseline in Dermatology Life Quality Index (DLQI) Score Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in DLQI score will be reported. The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10 item patient-reported outcome(s) (PRO) questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates more severe disease. -Parts 1 and 2: Change from Baseline in Hidradenitis Suppurativa Symptom Diary (HSSD-24 Hour) Score Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in HSSD-24 hour score will be reported. The HSSD is an 8-item patient self-reported questionnaire that assesses symptoms (including pain, tenderness, pressure, itch, heat, and odor) and signs (including swelling and drainage) of HS. The participants are asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. -Parts 1 and 2: Change from Baseline in Pain Scale Score of HSSD-24 Hour Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in pain scale score of HSSD-24 hour score will be reported. The HSSD is an 8-item patient self-reported questionnaire that assesses symptoms (including pain, tenderness, pressure, itch, heat, and odor) and signs (including swelling and drainage) of HS. The participants are asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. -Parts 1 and 2: Change from Baseline in Itch Scale Score of HSSD-24 Hour Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in itch scale score of HSSD-24 hour will be reported. The HSSD is an 8-item patient self-reported questionnaire that assesses symptoms (including pain, tenderness, pressure, itch, heat, and odor) and signs (including swelling and drainage) of HS. The participants are asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. -Parts 1 and 2: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Up to Week 36 An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline. See the attached pdf for the remaining.

Primary Outcome

-Part 1: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 HiSCR50 is defined as at least a 50 percent reduction from baseline in the total abscess and inflammatory nodule (AN) count with no increase in abscess or draining fistula count. Percentage of participants achieving HisCR50 will be reported. -Part 2: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 12 HiSCR50 is defined as at least a 50 percent reduction from baseline in the total AN count with no increase in abscess or draining fistula count. Percentage of participants achieving HisCR50 will be reported.

Secondary Outcome

-Part 1 and Part 2: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-75 (HiSCR75) Part 1: Week 16; Part 2: Week 12 HiSCR75 is defined as at least a 75 percent reduction from baseline in the total AN count with no increase in abscess or draining fistula count. Percentage of participants achieving HiSCR75 will be reported. -Part 1 and Part 2: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response-90 (HiSCR90) Part 1: Week 16; Part 2: Week 12 HiSCR90 is defined as at least a 90 percent reduction from baseline in the total AN count with no increase in abscess or draining fistula count. Percentage of participants achieving HiSCR90 will be reported. Parts 1 and 2: Change from Baseline in the (AN) Count Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in the AN count will be reported. -Parts 1 and 2: Percentage of Participants Achieving at Least 50 percent, 75 percent, 90 percent, and 100 percent Reduction in Total AN Count Part 1: Week 16; Part 2: Week 12 Percentage of participants achieving at least 50 percent, 75 percent, 90 percent, and 100 percent reduction in total AN count will be reported. -Parts 1 and 2: Percentage of Participants Achieving an AN Count of 0/1 and 0/1/2 Part 1: Week 16; Part 2: Week 12 Percentage of participants achieving an AN count of 0/1 and 0/1/2 will be reported. -Parts 1 and 2: Percentage of Participants Achieving Complete Elimination of Abscesses Among those Participants with Abscesses at Baseline Part 1: Week 16; Part 2: Week 12 Percentage of participants achieving complete elimination of abscesses among those participants with abscesses at baseline will be reported. -Parts 1 and 2: Change from Baseline in the Number of Abscesses Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in the number of abscesses will be reported. -Parts 1 and 2: Percentage of Participants Achieving Complete Elimination of Draining Fistulas Among those Participants with Draining Fistulas at Baseline Part 1: Week 16; Part 2: Week 12 Percentage of participants achieving complete elimination of abscesses among those participants with abscesses at baseline will be reported. -Parts 1 and 2: Change from Baseline in Number of Draining Fistulas Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in number of draining fistulas will be reported. - Parts 1 and 2: Percentage of Participants Achieving Complete Elimination of Inflammatory Nodules Among those Participants with Inflammatory Nodules at Baseline Part 1: Week 16; Part 2: Week 12 Percentage of participants achieving complete elimination of inflammatory nodules among those participants with inflammatory nodules at baseline will be reported. -Parts 1 and 2: Change from Baseline in Number of Inflammatory Nodules Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in number of inflammatory nodules will be reported. -Parts 1 and 2: Change from Baseline in International Hidradenitis Suppurativa Severity (IHS4) Score Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in IHS4 score will be reported. The IHS4 assesses the Hidradenitis Suppurativa (HS) severity and the resulting IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. -Parts 1 and 2: Percentage of Participants with Hidradenitis Suppurativa-Investigato's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild (2) and with at least 2-grade Part 1: Week 16; Part 2: Week 12 Percentage of participants with HS-IGA score of inactive (0), almost inactive (1), or mild (2) and with at least 2-grade improvement relative to baseline will be reported. The participant's HS is assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. -Parts 1 and 2: Percentage 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) at Baseline Part 1: Week 16; Part 2: Week 12 Percentage 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) at baseline will be reported. -Parts 1 and 2: Change from Baseline in Dermatology Life Quality Index (DLQI) Score Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in DLQI score will be reported. The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10 item patient-reported outcome(s) (PRO) questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates more severe disease. -Parts 1 and 2: Change from Baseline in Hidradenitis Suppurativa Symptom Diary (HSSD-24 Hour) Score Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in HSSD-24 hour score will be reported. The HSSD is an 8-item patient self-reported questionnaire that assesses symptoms (including pain, tenderness, pressure, itch, heat, and odor) and signs (including swelling and drainage) of HS. The participants are asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. -Parts 1 and 2: Change from Baseline in Pain Scale Score of HSSD-24 Hour Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in pain scale score of HSSD-24 hour score will be reported. The HSSD is an 8-item patient self-reported questionnaire that assesses symptoms (including pain, tenderness, pressure, itch, heat, and odor) and signs (including swelling and drainage) of HS. The participants are asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. -Parts 1 and 2: Change from Baseline in Itch Scale Score of HSSD-24 Hour Part 1: Baseline and Week 16; Part 2: Baseline and Week 12 Change from baseline in itch scale score of HSSD-24 hour will be reported. The HSSD is an 8-item patient self-reported questionnaire that assesses symptoms (including pain, tenderness, pressure, itch, heat, and odor) and signs (including swelling and drainage) of HS. The participants are asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. -Parts 1 and 2: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Up to Week 36 An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline. See the attached pdf for the remaining.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Inclusion Criteria: - Have hidradenitis suppurativa (HS) for at least 1 year (365 days) prior to the baseline visit as determined by the investigator through participant interview and/or review of the medical history - Have Hurley Stage II or Hurley Stage III HS as determined by the investigator at screening and baseline visits - Have HS lesions present in at least 2 distinct anatomic areas (examples include but are not limited to left and right axilla; or left axilla and left inguinocrural fold) at screening and baseline visits - Have a total abscess and inflammatory nodule (AN) count of greater than or equal to (>=)5 at the screening and baseline visit - Agree not to receive a live virus or live bacterial vaccination during the study and for 90 days after the last administration of study intervention
Exclude criteria	Exclusion Criteria: - 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 - Has unstable cardiovascular disease, defined as a recent clinical deterioration (that is, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months - Has or has had herpes zoster within the 2 months before screening - Has a transplanted organ (with exception of a corneal transplant greater than [>]3 months before the first administration of study intervention) - Has known allergies, hypersensitivity, or intolerance to bermekimab or adalimumab or its excipients

Related Information

Primary Sponsor	Nishikawa Kazuko
Secondary Sponsor
Source(s) of Monetary Support
Secondary ID(s)	NCT04988308,2020-002607-19

Contact

Public contact
Name	Medical Information Center
Address	5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo Tokyo Japan 101-0065
Telephone	+81-120-183-275
E-mail	DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Affiliation	Janssen Pharmaceutical K.K.
Scientific contact
Name	Kazuko Nishikawa
Address	5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo Tokyo Japan 101-0065
Telephone	+81-120-183-275
E-mail	DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Affiliation	Janssen Pharmaceutical K.K.

TO Original Data: JRCT