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

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

Study Description
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Brief Summary:
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Bimekizumab Drug: Adalimumab Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 22, 2017
Actual Primary Completion Date : November 23, 2018
Actual Study Completion Date : February 21, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bimekizumab
Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
 Drug: Bimekizumab
Bimekizumab in different dosages (dose 1 and 2).
Other Name: UCB4940
Active Comparator: Adalimumab
Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.
 Drug: Adalimumab
Adalimumab in different dosages (dose 1, 2 and 3).
Other Name: Humira®
Placebo Comparator: Placebo
Subjects will receive several placebo applications to keep the blinding.
 Other: Placebo
Placebo will be provided matching Bimekizumab.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Bimekizumab plasma concentration at Day 1 [ Time Frame: Day 1 ]
    Blood samples will be taken to determine Bimekizumab plasma concentration.

  2. Bimekizumab plasma concentration at Week 2 [ Time Frame: Week 2 ]
    Blood samples will be taken to determine Bimekizumab plasma concentration.

  3. Bimekizumab plasma concentration at Week 4 [ Time Frame: Week 4 ]
    Blood samples will be taken to determine Bimekizumab plasma concentration.

  4. Bimekizumab plasma concentration at Week 8 [ Time Frame: Week 8 ]
    Blood samples will be taken to determine Bimekizumab plasma concentration.

  5. Bimekizumab plasma concentration at Week 12 [ Time Frame: Week 12 ]
    Blood samples will be taken to determine Bimekizumab plasma concentration.

  6. Bimekizumab plasma concentration at Week 30 [ Time Frame: Week 30 ]
    Blood samples will be taken to determine Bimekizumab plasma concentration.

  7. 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.

  8. 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.

  9. 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

  10. 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'

  11. 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.

  12. 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

  13. 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

  14. 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

  15. 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.

  16. Change from Baseline hematology parameter [ Time Frame: From Screening until Safety Follow-Up (Week 30) ]
    Laboratory parameters will be collected at pre-specified visits.

  17. 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.

  18. 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.

  19. 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.

  20. Bimekizumab Anti-drug antibody (ADA) concentration at Day 1 [ Time Frame: Day 1 ]
    Blood samples will be taken to determine the Bimekizumab ADA concentration.

  21. Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 2 [ Time Frame: Week 2 ]
    Blood samples will be taken to determine the Bimekizumab ADA concentration.

  22. Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 4 [ Time Frame: Week 4 ]
    Blood samples will be taken to determine the Bimekizumab ADA concentration.

  23. Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 8 [ Time Frame: Week 8 ]
    Blood samples will be taken to determine the Bimekizumab ADA concentration.

  24. Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 12 [ Time Frame: Week 12 ]
    Blood samples will be taken to determine the Bimekizumab ADA concentration.

  25. Bimekizumab Anti-Drug Antibody (ADA) concentration at Week 30 [ Time Frame: Week 30 ]
    Blood samples will be taken to determine the Bimekizumab ADA concentration.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248531


Locations
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Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares +1-844-599-2273 (UCB)
More Information
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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03248531    
Other Study ID Numbers: HS0001
2017-000892-10 ( EudraCT Number )
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Hidradenitis Suppurativa
Bimekizumab
HS
Moderate to Severe HS
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
 Skin Diseases, Infectious
Infection
Suppuration
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents