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
• Results First Posted: February 9, 2022
• Last Update Posted: April 11, 2022
• Sponsor: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

Study Description

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

• 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

Arms and Interventions

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

Primary Outcome Measures :

1. Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: Week 12 ]
   HiSCR was 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. Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Participants with missing data at Week 12 were considered as nonresponders in the analysis. Posterior mean response rates and 95% credible intervals in each group are presented.

Secondary Outcome Measures :

1. Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose) [ Time Frame: Day 1 (Prior to first dose) ]
   Plasma concentration of Bimekizumab was expressed in nanograms per milliliter (ng/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (75 ng/mL) in calculations of Means and Coefficient of Variations (CVs).
2. Bimekizumab Plasma Concentration at Week 2 [ Time Frame: Week 2 ]
   Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
3. Bimekizumab Plasma Concentration at Week 4 [ Time Frame: Week 4 ]
   Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
4. Bimekizumab Plasma Concentration at Week 8 [ Time Frame: Week 8 ]
   Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
5. Bimekizumab Plasma Concentration at Week 12 [ Time Frame: Week 12 ]
   Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
6. Bimekizumab Plasma Concentration at Week 30 [ Time Frame: Week 30 ]
   Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
7. Percentage of Participants With at Least One Adverse Event During the Study [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
   An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
8. Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
   An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. To record the intensity of an AE Investigator used the following criteria: Mild: the study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with the usual activities of the study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.
9. Percentage of Participants With at Least One Serious Adverse Event During the Study [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
   A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalisation, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above.
10. Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
    A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above. To record the intensity of an AE Investigator used the following criteria: Mild: study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with usual activities of study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.
11. Percentage of Participants That Withdrew Due to Adverse Events During the Study [ Time Frame: From Screening to Safety Follow-Up (Week 30) ]
    An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
12. Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Blood pressure was measured in millimeters of mercury (mmHg).
13. Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Pulse rate was measured in beats per minute (beats/min).
14. Change From Baseline Until Safety Follow-up Visit in Body Weight [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Body weight was measured in kilograms (kg).
15. Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.
16. Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec).
17. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Erythrocytes was measured in number of red blood cells per liter (10^12/L).
18. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Hematocrit was measured in volume percentage (%) of red blood cells in blood.
19. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L).
20. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
21. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Erythrocytes mean corpuscular volume was measured in femtoliters (fL).
22. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Platelets was measured in number of platelets per liter (10^9/L).
23. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).
24. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%).
25. Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
26. Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Creatinine, bilirubin, and urate were measured in micromols per liter (μmol/L).
27. Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    C reactive protein high sensitivity was measured in milligrams per liter (mg/L).
28. Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
29. Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Urine pH was measured on a pH scale.
30. Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
    Urine albumin was measured in milligrams per liter (mg/L).
31. Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
32. Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
33. Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
34. Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes) [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
35. Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination [ Time Frame: From Baseline to Safety Follow-Up (Week 30) ]
36. Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1 [ Time Frame: Day 1 ]
    The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
37. Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2 [ Time Frame: Week 2 ]
    The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
38. Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4 [ Time Frame: Week 4 ]
    The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
39. Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8 [ Time Frame: Week 8 ]
    The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
40. Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12 [ Time Frame: Week 12 ]
    The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
41. Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30 [ Time Frame: Week 30 ]
    The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.

Eligibility Criteria

• 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

Locations

United States, California

Hs0001 121

Los Angeles, California, United States, 90033

United States, Florida

Hs0001 119

Coral Gables, Florida, United States, 33134

Hs0001 111

Orange, Florida, United States, 32073

Hs0001 117

Tampa, Florida, United States, 33624

United States, Georgia

Hs0001 112

Sandy Springs, Georgia, United States, 30328

United States, Massachusetts

Hs0001 113

Boston, Massachusetts, United States, 02215

United States, Nevada

Hs0001 115

Las Vegas, Nevada, United States, 89074

United States, New York

Hs0001 126

Manhasset, New York, United States, 11030

United States, North Carolina

Hs0001 125

Chapel Hill, North Carolina, United States, 27599

United States, Pennsylvania

Hs0001 123

Hershey, Pennsylvania, United States, 17033

United States, Tennessee

Hs0001 120

Nashville, Tennessee, United States, 37215

Australia

Hs0001 103

East Melbourne, Australia

Hs0001 101

Fremantle, Australia

Hs0001 104

Saint Leonards, Australia

Hs0001 100

Westmead, Australia

Hs0001 102

Woolloongabba, Australia

Belgium

Hs0001 203

Brussels, Belgium

Hs0001 202

Liège, Belgium

Denmark

Hs0001 300

Copenhagen, Denmark

Germany

Hs0001 408

Berlin, Germany

Hs0001 405

Bochum, Germany

Hs0001 407

Darmstadt, Germany

Hs0001 400

Dessau, Germany

Hs0001 404

Erlangen, Germany

Hs0001 406

Würzburg, Germany

Greece

Hs0001 503

Athens, Greece

Norway

Hs0001 701

Harstad, Norway

Hs0001 700

Tromsø, Norway

Russian Federation

Hs0001 901

Moscow, Russian Federation

Hs0001 903

Saint Petersburg, Russian Federation

Hs0001 900

Yaroslavl, Russian Federation

Sponsors and Collaborators

UCB Biopharma SRL

Investigators

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

  Study Documents (Full-Text)

Documents provided by UCB Pharma ( UCB Biopharma SRL ):

Study Protocol  [PDF] March 8, 2018

Statistical Analysis Plan  [PDF] February 19, 2019

More Information

Publications of Results:

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. Erratum in: JAMA Dermatol. 2021 Nov 1;157(11):1384.

• Responsible Party: UCB Biopharma SRL
• ClinicalTrials.gov Identifier: NCT03248531
• Other Study ID Numbers: HS0001; 2017-000892-10 ( EudraCT Number )
• First Posted: August 14, 2017
• Results First Posted: February 9, 2022
• Last Update Posted: April 11, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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 SRL ):

Hidradenitis Suppurativa; Bimekizumab; HS; Moderate to Severe HS

Additional relevant MeSH terms:

Hidradenitis Suppurativa; Hidradenitis; Sweat Gland Diseases; Skin Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Adalimumab; Anti-Inflammatory Agents; Antirheumatic Agents