A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.

• ClinicalTrials.gov Identifier: NCT03248531
• Recruitment Status: Completed
• First Posted: August 14, 2017
• Last Update Posted: March 20, 2020
• Sponsor: UCB Biopharma S.P.R.L.
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information

• First Submitted Date: August 2, 2017
• First Posted Date: August 14, 2017
• Last Update Posted Date: March 20, 2020
• Actual Study Start Date: September 22, 2017
• Actual Primary Completion Date: November 23, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 11, 2017)

Percentage of subjects achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: Week 12 ]

HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 18, 2017)

• Bimekizumab plasma concentration at Day 1 [ Time Frame: Day 1 ]
  Blood samples will be taken to determine Bimekizumab plasma concentration.
• Bimekizumab plasma concentration at Week 2 [ Time Frame: Week 2 ]
  Blood samples will be taken to determine Bimekizumab plasma concentration.
• Bimekizumab plasma concentration at Week 4 [ Time Frame: Week 4 ]
  Blood samples will be taken to determine Bimekizumab plasma concentration.
• Bimekizumab plasma concentration at Week 8 [ Time Frame: Week 8 ]
  Blood samples will be taken to determine Bimekizumab plasma concentration.
• Bimekizumab plasma concentration at Week 12 [ Time Frame: Week 12 ]
  Blood samples will be taken to determine Bimekizumab plasma concentration.
• Bimekizumab plasma concentration at Week 30 [ Time Frame: Week 30 ]
  Blood samples will be taken to determine Bimekizumab plasma concentration.
• Number of Adverse Events (AE) [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
  An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug (medicinal product). The event does not necessarily have a causal relationship with that treatment or usage.
• Number of Adverse Events categorized by severity [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
  An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug (medicinal product). The event does not necessarily have a causal relationship with that treatment or usage.
• Number of Serious Adverse Events (SAEs) [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
  A SAE is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalization or prolongation of existing hospitalisation
  • Is a congenital anomaly or birth defect
  • Is as infection that requires treatment parenteral antibiotics
  • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
• Number of Serious Adverse Events (SAEs) categorized by severity [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
  A SAE is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalization or prolongation of existing hospitalisation
  • Is a congenital anomaly or birth defect
  • Is as infection that requires treatment parenteral antibiotics
  • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above'
• Number of subjects withdrawing due to Adverse Events [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
  An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug (medicinal product). The event does not necessarily have a causal relationship with that treatment or usage.
• Change from Baseline in vital signs (blood pressure [BP]) [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
  Vital signs will be collected at pre-specified visits
• Change from Baseline in vital signs (pulse rate) [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
  Vital signs will be collected at pre-specified visits
• Change from Baseline in body weight [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
  Body weight will be collected at pre-specified visits
• Change from Baseline in ECG parameters [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
  Twelve-lead standard ECGs will be recorded at pre-specified visits.
• Change from Baseline hematology parameter [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
  Laboratory parameters will be collected at pre-specified visits.
• Change from Baseline in biochemistry parameter [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
  Laboratory parameters will be collected at pre-specified visits.
• Change from Baseline in urinalysis parameter [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
  Laboratory parameters will be collected at pre-specified visits.
• Change from Baseline in physical examination [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
  Physical examination will be performed at pre-specified visits.
• Bimekizumab Anti-drug antibody (ADA) concentration at Day 1 [ Time Frame: Day 1 ]
  Blood samples will be taken to determine the Bimekizumab ADA concentration.
• Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 2 [ Time Frame: Week 2 ]
  Blood samples will be taken to determine the Bimekizumab ADA concentration.
• Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 4 [ Time Frame: Week 4 ]
  Blood samples will be taken to determine the Bimekizumab ADA concentration.
• Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 8 [ Time Frame: Week 8 ]
  Blood samples will be taken to determine the Bimekizumab ADA concentration.
• Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 12 [ Time Frame: Week 12 ]
  Blood samples will be taken to determine the Bimekizumab ADA concentration.
• Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 30 [ Time Frame: Week 30 ]
  Blood samples will be taken to determine the Bimekizumab ADA concentration.

Original Secondary Outcome Measures (submitted: August 11, 2017)

• Bimekizumab plasma concentration at Day 1 [ Time Frame: Day 1 ]
  Blood samples will be taken to determine Bimekizumab plasma concentration.
• Bimekizumab plasma concentration at Week 2 [ Time Frame: Week 2 ]
  Blood samples will be taken to determine Bimekizumab plasma concentration.
• Bimekizumab plasma concentration at Week 4 [ Time Frame: Week 4 ]
  Blood samples will be taken to determine Bimekizumab plasma concentration.
• Bimekizumab plasma concentration at Week 8 [ Time Frame: Week 8 ]
  Blood samples will be taken to determine Bimekizumab plasma concentration.
• Bimekizumab plasma concentration at Week 12 [ Time Frame: Week 12 ]
  Blood samples will be taken to determine Bimekizumab plasma concentration.
• Bimekizumab plasma concentration at Week 30 [ Time Frame: Week 30 ]
  Blood samples will be taken to determine Bimekizumab plasma concentration.
• Number of Adverse Events (AE) [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
  An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug (medicinal product). The event does not necessarily have a causal relationship with that treatment or usage.
• Number of Adverse Events categorized by severity [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
  An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug (medicinal product). The event does not necessarily have a causal relationship with that treatment or usage.
• Number of Serious Adverse Events (SAEs) [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
  A SAE is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalization or prolongation of existing hospitalisation
  • Is a congenital anomaly or birth defect
  • Is as infection that requires treatment parenteral antibiotics
  • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
• Number of Serious Adverse Events (SAEs) categorized by severity [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
  A SAE is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalization or prolongation of existing hospitalisation
  • Is a congenital anomaly or birth defect
  • Is as infection that requires treatment parenteral antibiotics
  • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above'
• Number of subjects withdrawing due to Adverse Events [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
  An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug (medicinal product). The event does not necessarily have a causal relationship with that treatment or usage.
• Change from Baseline in vital signs (blood pressure [BP] and pulse rate) and body weight [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
  Vital signs and body weight will be collected at pre-specified visits.
• Change from Baseline in ECG parameters [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
  Twelve-lead standard ECGs will be recorded at pre-specified visits.
• Change from Baseline in clinical laboratory parameters (hematology, biochemistry, and urinalysis) [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
  Laboratory parameters will be collected at pre-specified visits.
• Change from Baseline in physical examination [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
  Physical examination will be performed at pre-specified visits.
• Bimekizumab Anti-drug antibody (ADA) concentration at Day 1 [ Time Frame: Day 1 ]
  Blood samples will be taken to determine the Bimekizumab ADA concentration
• Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 2 [ Time Frame: Week 2 ]
  Blood samples will be taken to determine the Bimekizumab ADA concentration
• Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 4 [ Time Frame: Week 4 ]
  Blood samples will be taken to determine the Bimekizumab ADA concentration
• Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 8 [ Time Frame: Week 8 ]
  Blood samples will be taken to determine the Bimekizumab ADA concentration
• Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 12 [ Time Frame: Week 12 ]
  Blood samples will be taken to determine the Bimekizumab ADA concentration
• Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 30 [ Time Frame: Week 30 ]
  Blood samples will be taken to determine the Bimekizumab ADA concentration

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
• Official Title: A Phase 2 Multicenter, Investigator-Blind, Subject-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
• Brief Summary: Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hidradenitis Suppurativa

Intervention

• Drug: Bimekizumab
  Bimekizumab in different dosages (dose 1 and 2).
  Other Name: UCB4940
• Drug: Adalimumab
  Adalimumab in different dosages (dose 1, 2 and 3).
  Other Name: Humira®
• Other: Placebo
  Placebo will be provided matching Bimekizumab.

Study Arms

• Experimental: Bimekizumab
  Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
  Intervention: Drug: Bimekizumab
• Active Comparator: Adalimumab
  Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.
  Intervention: Drug: Adalimumab
• Placebo Comparator: Placebo
  Subjects will receive several placebo applications to keep the blinding.
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 18, 2020): 90
• Original Estimated Enrollment (submitted: August 11, 2017): 160
• Actual Study Completion Date: February 21, 2019
• Actual Primary Completion Date: November 23, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at least

  1 year prior to Baseline

• Stable HS for at least 2 months prior to Screening and also at the Baseline Visit
• Inadequate response to at least a 3-month study of an oral antibiotic for treatment of HS
• Total abscess and inflammatory nodule count >=3 at the Baseline Visit
• Subject must agree to daily use (and throughout the entirety of the study) of 1 pre-specified over-the-counter topical antiseptics on their HS lesions
• Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
• Male subjects must be willing to use a method of contraception when sexually active, up till 20 weeks after the last administration of study medication

Exclusion Criteria:

• Prior treatment with anti-IL17s or participation in an anti-IL17 study
• Previously received anti-TNFs
• Subject requires, or is expected to require, opioid analgesics for any reason (excluding tramadol)
• Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline Visit
• Subject received systemic non-biologic therapies for HS with potential therapeutic impact for HS less than 28 days prior to Baseline Visit
• Draining fistula count >20 at the Baseline Visit
• Diagnosis of inflammatory conditions other than HS

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Denmark, Germany, Greece, Norway, Russian Federation, United States

Administrative Information

• NCT Number: NCT03248531
• Other Study ID Numbers: HS0001; 2017-000892-10 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
• Study Sponsor: UCB Biopharma S.P.R.L.
• Collaborators: Not Provided

Investigators

• Study Director: UCB Cares; +1-844-599-2273 (UCB)

• PRS Account: UCB Pharma
• Verification Date: March 2020