Clinical trial NCT03248531: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Bimekizumab
HS
Moderate to Severe HS
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-08-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)
timeFrame: Day 1 (Prior to first dose)
measure: Bimekizumab Plasma Concentration at Week 2
timeFrame: Week 2
measure: Bimekizumab Plasma Concentration at Week 4
timeFrame: Week 4
measure: Bimekizumab Plasma Concentration at Week 8
timeFrame: Week 8
measure: Bimekizumab Plasma Concentration at Week 12
timeFrame: Week 12
measure: Bimekizumab Plasma Concentration at Week 30
timeFrame: Week 30
measure: Percentage of Participants With at Least One Adverse Event During the Study
timeFrame: From Screening to Safety Follow-Up (Week 30)
measure: Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study
timeFrame: From Screening to Safety Follow-Up (Week 30)
measure: Percentage of Participants With at Least One Serious Adverse Event During the Study
timeFrame: From Screening to Safety Follow-Up (Week 30)
measure: Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study
timeFrame: From Screening to Safety Follow-Up (Week 30)
measure: Percentage of Participants That Withdrew Due to Adverse Events During the Study
timeFrame: From Screening to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Body Weight
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination
timeFrame: From Baseline to Safety Follow-Up (Week 30)
measure: Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1
timeFrame: Day 1
measure: Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2
timeFrame: Week 2
measure: Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4
timeFrame: Week 4
measure: Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8
timeFrame: Week 8
measure: Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30
timeFrame: Week 30
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Hs0001 121
state: California
city: Coral Gables
country: United States
facility: Hs0001 119
state: Florida
city: Orange
country: United States
facility: Hs0001 111
state: Florida
city: Tampa
country: United States
facility: Hs0001 117
state: Florida
city: Sandy Springs
country: United States
facility: Hs0001 112
state: Georgia
city: Boston
country: United States
facility: Hs0001 113
state: Massachusetts
city: Las Vegas
country: United States
facility: Hs0001 115
state: Nevada
city: Manhasset
country: United States
facility: Hs0001 126
state: New York
city: Chapel Hill
country: United States
facility: Hs0001 125
state: North Carolina
city: Hershey
country: United States
facility: Hs0001 123
state: Pennsylvania
city: Nashville
country: United States
facility: Hs0001 120
state: Tennessee
city: East Melbourne
country: Australia
facility: Hs0001 103
city: Fremantle
country: Australia
facility: Hs0001 101
city: Saint Leonards
country: Australia
facility: Hs0001 104
city: Westmead
country: Australia
facility: Hs0001 100
city: Woolloongabba
country: Australia
facility: Hs0001 102
city: Brussels
country: Belgium
facility: Hs0001 203
city: Liège
country: Belgium
facility: Hs0001 202
city: Copenhagen
country: Denmark
facility: Hs0001 300
city: Berlin
country: Germany
facility: Hs0001 408
city: Bochum
country: Germany
facility: Hs0001 405
city: Darmstadt
country: Germany
facility: Hs0001 407
city: Dessau
country: Germany
facility: Hs0001 400
city: Erlangen
country: Germany
facility: Hs0001 404
city: Würzburg
country: Germany
facility: Hs0001 406
city: Athens
country: Greece
facility: Hs0001 503
city: Harstad
country: Norway
facility: Hs0001 701
city: Tromsø
country: Norway
facility: Hs0001 700
city: Moscow
country: Russian Federation
facility: Hs0001 901
city: Saint Petersburg
country: Russian Federation
facility: Hs0001 903
city: Yaroslavl
country: Russian Federation
facility: Hs0001 900
Study officials:
affiliation: +1-844-599-2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Glatt S, Jemec GBE, Forman S, Sayed C, Schmieder G, Weisman J, Rolleri R, Seegobin S, Baeten D, Ionescu L, Zouboulis CC, Shaw S. Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: A Phase 2, Double-blind, Placebo-Controlled Randomized Clinical Trial. JAMA Dermatol. 2021 Nov 1;157(11):1279-1288. doi: 10.1001/jamadermatol.2021.2905.