Hidradenitis SuppurativaPhase 2NCT03248531
A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
A Phase 2 study testing Bimekizumab and Adalimumab in people with Hidradenitis Suppurativa, run by UCB Biopharma SRL at 31 sites in 8 countries.
Trial summary
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Bimekizumab and Adalimumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 31 sitesin 8 countries
- Study dates
- 22 Sep 2017to 21 Feb 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
United States11 sites
Hs0001 113
Boston, Massachusetts, 02215
Hs0001 125
Chapel Hill, North Carolina, 27599
Hs0001 119
Coral Gables, Florida, 33134
Hs0001 123
Hershey, Pennsylvania, 17033
Hs0001 115
Las Vegas, Nevada, 89074
Hs0001 121
Los Angeles, California, 90033
Hs0001 126
Manhasset, New York, 11030
Hs0001 120
Nashville, Tennessee, 37215
Hs0001 111
Orange, Florida, 32073
Hs0001 112
Sandy Springs, Georgia, 30328
Hs0001 117
Tampa, Florida, 33624
Germany6 sites
Hs0001 408
Berlin
Hs0001 405
Bochum
Hs0001 407
Darmstadt
Hs0001 400
Dessau
Hs0001 404
Erlangen
Hs0001 406
Würzburg
Australia5 sites
Hs0001 103
East Melbourne
Hs0001 101
Fremantle
Hs0001 104
Saint Leonards
Hs0001 100
Westmead
Hs0001 102
Woolloongabba
About this study
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
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Bimekizumab, Adalimumab, Placebo
- Keywords
- Hidradenitis Suppurativa, Bimekizumab, HS, Moderate to Severe HS
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimekizumabDrug
Also called UCB4940
Bimekizumab in different dosages (dose 1 and 2).
AdalimumabDrug
Also called Humira®
Adalimumab in different dosages (dose 1, 2 and 3).
PlaceboOther
Placebo will be provided matching Bimekizumab.
| Study group | Role | What they receive |
|---|---|---|
| Bimekizumab | Experimental | Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications. Receives: Drug: Bimekizumab |
| Adalimumab | Active comparator | Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications. Receives: Drug: Adalimumab |
| Placebo | Placebo comparator | Subjects will receive several placebo applications to keep the blinding. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (41)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 8
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.
Measured: Week 12
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.
Measured: Week 30
Percentage of Participants With at Least One Adverse Event 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.
Measured: 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.
Measured: From Screening to Safety Follow-Up (Week 30)
Percentage of Participants With at Least One Serious Adverse Event 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 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.
Measured: 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.
Measured: From Screening to Safety Follow-Up (Week 30)
Percentage of Participants That Withdrew Due to Adverse Events 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.
Measured: 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).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
Pulse rate was measured in beats per minute (beats/min).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Body Weight
Body weight was measured in kilograms (kg).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)
Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval)
PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
Erythrocytes was measured in number of red blood cells per liter (10^12/L).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration)
Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
Erythrocytes mean corpuscular volume was measured in femtoliters (fL).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Platelets was measured in number of platelets per liter (10^9/L).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils)
Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes)
Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose)
Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)
Creatinine, bilirubin, and urate were measured in micromols per liter (μmol/L).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)
C reactive protein high sensitivity was measured in milligrams per liter (mg/L).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)
Urine pH was measured on a pH scale.
Measured: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)
Urine albumin was measured in milligrams per liter (mg/L).
Measured: From Baseline to Safety Follow-Up (Week 30)
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)
Measured: From Baseline to Safety Follow-Up (Week 30)
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)
Measured: From Baseline to Safety Follow-Up (Week 30)
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)
Measured: From Baseline to Safety Follow-Up (Week 30)
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)
Measured: From Baseline to Safety Follow-Up (Week 30)
Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination
Measured: From Baseline to Safety Follow-Up (Week 30)
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at 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.
Measured: Day 1
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at 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.
Measured: Week 2
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at 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.
Measured: Week 4
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at 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.
Measured: Week 8
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at 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.
Measured: Week 12
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at 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.
Measured: Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start22 Sep 2017
- Primary completion23 Nov 2018
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1-844-599-2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248531
- Sponsor's protocol ID
- HS0001
- Other IDs
- 2017-000892-10, 2017
- Status last verified
- Jan 2022
- First submitted
- 2 Aug 2017
- Last updated
- 11 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34406364
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03248531
- Acronym / sponsor ID
- HS0001
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, Bimekizumab, HS, Moderate to Severe HS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Posted 9 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bimekizumab | Experimental | Drug: BimekizumabSubjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications. |
| Adalimumab | Active comparator | Drug: AdalimumabSubjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications. |
| Placebo | Placebo comparator | Other: PlaceboSubjects will receive several placebo applications to keep the blinding. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BimekizumabAlso: UCB4940Bimekizumab in different dosages (dose 1 and 2). | Drug | Bimekizumab |
| AdalimumabAlso: Humira®Adalimumab in different dosages (dose 1, 2 and 3). | Drug | Adalimumab |
| PlaceboPlacebo will be provided matching Bimekizumab. | Other | Placebo |
Primary outcome
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.
41 secondary outcomes
Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)
Time frame: Day 1 (Prior to first dose)
Bimekizumab Plasma Concentration at Week 2
Time frame: Week 2
Bimekizumab Plasma Concentration at Week 4
Time frame: Week 4
Bimekizumab Plasma Concentration at Week 8
Time frame: Week 8
Bimekizumab Plasma Concentration at Week 12
Time frame: Week 12
Bimekizumab Plasma Concentration at Week 30
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
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
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)
Time frame: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
Time frame: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Body Weight
Time frame: From Baseline to Safety Follow-Up (Week 30)
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)
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)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
Time frame: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Time frame: From Baseline to Safety Follow-Up (Week 30)
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)
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)
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)
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Time frame: From Baseline to Safety Follow-Up (Week 30)
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)
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)
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)
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)
Time frame: From Baseline to Safety Follow-Up (Week 30)
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)
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)
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)
Time frame: From Baseline to Safety Follow-Up (Week 30)
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)
Time frame: From Baseline to Safety Follow-Up (Week 30)
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)
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)
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)
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)
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)
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1
Time frame: Day 1
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2
Time frame: Week 2
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4
Time frame: Week 4
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8
Time frame: Week 8
Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34406364Glatt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
+1-844-599-2273 (UCB)
31 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bimekizumab and Adalimumab in people with Hidradenitis Suppurativa, run by UCB Biopharma SRL at 31 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Germany, Australia, Russia, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.