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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03248531




Registration number
NCT03248531
Ethics application status
Date submitted
2/08/2017
Date registered
14/08/2017

Titles & IDs
Public title
A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
Scientific 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
Secondary ID [1] 0 0
2017-000892-10
Secondary ID [2] 0 0
HS0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Treatment: Drugs - Adalimumab
Other interventions - Placebo

Experimental: Bimekizumab - Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.

Active comparator: Adalimumab - Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.

Placebo comparator: Placebo - Subjects will receive several placebo applications to keep the blinding.


Treatment: Drugs: Bimekizumab
Bimekizumab in different dosages (dose 1 and 2).

Treatment: Drugs: Adalimumab
Adalimumab in different dosages (dose 1, 2 and 3).

Other interventions: Placebo
Placebo will be provided matching Bimekizumab.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)
Timepoint [1] 0 0
Day 1 (Prior to first dose)
Secondary outcome [2] 0 0
Bimekizumab Plasma Concentration at Week 2
Timepoint [2] 0 0
Week 2
Secondary outcome [3] 0 0
Bimekizumab Plasma Concentration at Week 4
Timepoint [3] 0 0
Week 4
Secondary outcome [4] 0 0
Bimekizumab Plasma Concentration at Week 8
Timepoint [4] 0 0
Week 8
Secondary outcome [5] 0 0
Bimekizumab Plasma Concentration at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Bimekizumab Plasma Concentration at Week 30
Timepoint [6] 0 0
Week 30
Secondary outcome [7] 0 0
Percentage of Participants With at Least One Adverse Event During the Study
Timepoint [7] 0 0
From Screening to Safety Follow-Up (Week 30)
Secondary outcome [8] 0 0
Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study
Timepoint [8] 0 0
From Screening to Safety Follow-Up (Week 30)
Secondary outcome [9] 0 0
Percentage of Participants With at Least One Serious Adverse Event During the Study
Timepoint [9] 0 0
From Screening to Safety Follow-Up (Week 30)
Secondary outcome [10] 0 0
Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study
Timepoint [10] 0 0
From Screening to Safety Follow-Up (Week 30)
Secondary outcome [11] 0 0
Percentage of Participants That Withdrew Due to Adverse Events During the Study
Timepoint [11] 0 0
From Screening to Safety Follow-Up (Week 30)
Secondary outcome [12] 0 0
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
Timepoint [12] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [13] 0 0
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
Timepoint [13] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [14] 0 0
Change From Baseline Until Safety Follow-up Visit in Body Weight
Timepoint [14] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [15] 0 0
Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)
Timepoint [15] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [16] 0 0
Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval)
Timepoint [16] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [17] 0 0
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
Timepoint [17] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [18] 0 0
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Timepoint [18] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [19] 0 0
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration)
Timepoint [19] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [20] 0 0
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Timepoint [20] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [21] 0 0
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
Timepoint [21] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [22] 0 0
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Timepoint [22] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [23] 0 0
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils)
Timepoint [23] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [24] 0 0
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes)
Timepoint [24] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [25] 0 0
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose)
Timepoint [25] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [26] 0 0
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)
Timepoint [26] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [27] 0 0
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)
Timepoint [27] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [28] 0 0
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Timepoint [28] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [29] 0 0
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)
Timepoint [29] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [30] 0 0
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)
Timepoint [30] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [31] 0 0
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)
Timepoint [31] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [32] 0 0
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)
Timepoint [32] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [33] 0 0
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)
Timepoint [33] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [34] 0 0
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)
Timepoint [34] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [35] 0 0
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination
Timepoint [35] 0 0
From Baseline to Safety Follow-Up (Week 30)
Secondary outcome [36] 0 0
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1
Timepoint [36] 0 0
Day 1
Secondary outcome [37] 0 0
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2
Timepoint [37] 0 0
Week 2
Secondary outcome [38] 0 0
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4
Timepoint [38] 0 0
Week 4
Secondary outcome [39] 0 0
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8
Timepoint [39] 0 0
Week 8
Secondary outcome [40] 0 0
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12
Timepoint [40] 0 0
Week 12
Secondary outcome [41] 0 0
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30
Timepoint [41] 0 0
Week 30

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/02/2019
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Hs0001 103 - East Melbourne
Recruitment hospital [2] 0 0
Hs0001 101 - Fremantle
Recruitment hospital [3] 0 0
Hs0001 104 - Saint Leonards
Recruitment hospital [4] 0 0
Hs0001 100 - Westmead
Recruitment hospital [5] 0 0
Hs0001 102 - Woolloongabba
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment postcode(s) [2] 0 0
- Fremantle
Recruitment postcode(s) [3] 0 0
- Saint Leonards
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
Belgium
State/province [10] 0 0
Brussels
Country [11] 0 0
Belgium
State/province [11] 0 0
Liège
Country [12] 0 0
Denmark
State/province [12] 0 0
Copenhagen
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Bochum
Country [15] 0 0
Germany
State/province [15] 0 0
Darmstadt
Country [16] 0 0
Germany
State/province [16] 0 0
Dessau
Country [17] 0 0
Germany
State/province [17] 0 0
Erlangen
Country [18] 0 0
Germany
State/province [18] 0 0
Würzburg
Country [19] 0 0
Greece
State/province [19] 0 0
Athens
Country [20] 0 0
Norway
State/province [20] 0 0
Harstad
Country [21] 0 0
Norway
State/province [21] 0 0
Tromsø
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Moscow
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Saint Petersburg
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Yaroslavl

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma SRL
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
+1-844-599-2273 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Glatt S, Jemec GBE, Forman S, Sayed C, Schmieder G... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT03248531