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

Phase 2CompletedNCT03248531

UCB Biopharma SRL90 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

BimekizumabDRUG

Bimekizumab in different dosages (dose 1 and 2).

AdalimumabDRUG

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

PlaceboOTHER

Placebo will be provided matching Bimekizumab.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (31)

Hs0001 121

Los Angeles, California, United States

Outcomes

Primary Outcomes

Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at 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.

Time frame: Week 12

Secondary Outcomes

Bimekizumab Plasma Concentration at 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).

Time frame: Day 1 (Prior to first dose)

Bimekizumab Plasma Concentration at 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.

Time frame: Week 2

Bimekizumab Plasma Concentration at 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.

Time frame: Week 4

Bimekizumab Plasma Concentration at 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.

Time frame: Week 8

Data from ClinicalTrials.gov

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Hs0001 119

Coral Gables, Florida, United States

Hs0001 111

Orange, Florida, United States

Hs0001 117

Tampa, Florida, United States

Hs0001 112

Sandy Springs, Georgia, United States

Hs0001 113

Boston, Massachusetts, United States

Hs0001 115

Las Vegas, Nevada, United States

Hs0001 126

Manhasset, New York, United States

Hs0001 125

Chapel Hill, North Carolina, United States

Hs0001 123

Hershey, Pennsylvania, United States

...and 21 more locations

Bimekizumab Plasma Concentration at 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.

Bimekizumab Plasma Concentration at 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.

Time frame: Week 30

Percentage of Participants With at Least One Adverse Event During the Study

Time frame: From Screening to Safety Follow-Up (Week 30)

Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study

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.

Time frame: From Screening to Safety Follow-Up (Week 30)

Percentage of Participants With at Least One Serious Adverse Event During the Study

Time frame: From Screening to Safety Follow-Up (Week 30)

Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study

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.

Time frame: From Screening to Safety Follow-Up (Week 30)

Percentage of Participants That Withdrew Due to Adverse Events During the Study

Time frame: From Screening to Safety Follow-Up (Week 30)

Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)

Blood pressure was measured in millimeters of mercury (mmHg).