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
- Conditions
- acne inversa10014982
- Registration Number
- NL-OMON44288
- Lead Sponsor
- CB Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 16
To be eligible to participate in this study, all of the following criteria must be met:
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF) is signed and dated by the subject or by the legal representative.
2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator.
3. Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at least 1 year prior to Baseline.
4. Hidradenitis suppurativa lesions must be present in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III.
5. Subject must have stable HS for at least 2 months prior to Screening and also at the Baseline Visit as assessed by the Investigator through subject interview and review of medical history.
6. Subject must have had an inadequate response to at least a 3-month study of an oral antibiotic for treatment of HS (or exhibited recurrence after discontinuation to, or demonstrated intolerance to, or have a contraindication to oral antibiotics for treatment of their HS) as assessed by the Investigator through subject interview and review of medical history.
7. Subject must have a total abscess and inflammatory nodule count *3 at the Baseline Visit.
8. Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with adalimumab per regional labeling.
9. Subject must have a C-reactive protein (CRP) level >3mg/L at the Baseline Visit.
10. Subject has a negative tuberculosis (TB) Screening assessment (including an interferon gamma release assay [IGRA] test using QuantiFERON-TB Gold test, or equivalent) and negative posterior-anterior chest x-ray (CXR) or Computed Axial Tomography (CAT) scan of chest at Screening or within 3 months prior to Screening (nuclear magnetic resonance films are not acceptable).
11. Subject must agree to daily use (and throughout the entirety of the study) of 1 of the following over-the-counter topical antiseptics on their HS lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach in bathwater.
12. Subject is assessed to have no other medical condition that would preclude their participation in the study, as determined by the Principal Investigator based upon the results of a medical history, physical examination, laboratory profile, and a 12-lead ECG performed during the Screening Period, and confirmed at Baseline.
13. Female subjects must be postmenopausal (at least 1 year; to be confirmed hormonally as part of the Screening process, if less than 2 years since last menstrual period), permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of IMP, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose. The following methods are considered highly effective when used consistently and correctly.
-combined (estrogen and progestogen) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
-progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable,
Subjects are not permitted to enroll in the study if any of the following criteria is met:
1. Prior treatment with anti IL17s or participation in an anti-IL17 study.
2. Subjects who previously received anti-TNFs.
3. Subjects participating in another study of a medication or a medical device under investigation within the last 3 months or at least 5 half-lives of the investigational product, whichever is greater, or is currently participating in another study of a medication or medical device under investigation.
4. Subject has a known hypersensitivity to any excipient(s) of bimekizumab or adalimumab.
5. Subject is using concomitant oral analgesics for HS-related or non-HS-related pain at study entry:
-Opioid analgesics within 14 days prior to the Baseline Visit.
-Non-opioid oral analgesics unless at a stable dose for at least 14 days prior to the Baseline Visit (PRN use is not considered a stable dose).
6. Subject requires, or is expected to require, opioid analgesics for any reason (excluding tramadol).
7. Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline Visit.
8. Subject received systemic non-biologic therapies for HS with potential therapeutic impact for HS less than 28 days prior to Baseline Visit.
9. Subject has a draining fistula count >20 at the Baseline Visit.
10. Subjects with a diagnosis of inflammatory conditions other than HS, including but not limited to PSO, PsA, RA, sarcoidosis, or systemic lupus erythematosus. Subjects with a diagnosis of CD or ulcerative colitis are allowed as long as they have no active symptomatic disease at Screening or Baseline.
11. Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster). Subjects with a high risk of infection in the Investigator*s opinion (eg, subjects with leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections, prior prosthetic joint infection at any time, subjects who are permanently bedridden or wheelchair assisted).
12. Subject has any current sign or symptom that may indicate an active infection (except for common cold), or has had an infection requiring systemic antibiotics within 2 weeks of the Baseline Visit.
13. Any other active skin disease or condition (eg, bacterial, fungal or viral infection) that may interfere with assessment of HS.
14. Subject has history of or current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria (NTMB), Blastomyces, or Aspergillus or current active Candidiasis (local or systemic).
15. Subject has acute or chronic viral hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection. Subjects who have evidence of, or tested positive for, hepatitis B or hepatitis C are excluded.
-A positive test for the HBV is defined as: 1) positive for hepatitis B surface antigen; or, 2) positive for anti-hepatitis B core antibody.
-A positive test for the HCV is defined as: 1) positive for hepatitis C antibody, and 2) positive via a confirmatory test for HCV (for example, HCV polymerase chain reaction).
16. Subjects with known TB infection, at high risk of acquiring TB infection, with latent TB infection (LTB), or current or history of NTMB infection (refer to Section 11.3.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary End Point<br /><br><br /><br>Percentage of subjects achieving clinical response as measured by Hidradenitis<br /><br>Suppurativa Clinical Response (HiSCR).<br /><br><br /><br>Timepoint(s) of evaluation of this end point: Baseline, Week 12</p><br>
- Secondary Outcome Measures
Name Time Method