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Trial record 1 of 1 for:    NCT02905006
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Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis (BE ABLE 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02905006
Recruitment Status : Completed
First Posted : September 19, 2016
Results First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief Summary:
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: Bimekizumab Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Start Date : August 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.

Experimental: Bimekizumab dosing regimen 1 Drug: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Other Name: UCB4940

Other: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.

Experimental: Bimekizumab dosing regimen 2 Drug: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Other Name: UCB4940

Other: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.

Experimental: Bimekizumab dosing regimen 3 Drug: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Other Name: UCB4940

Other: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.

Experimental: Bimekizumab dosing regimen 4 Drug: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Other Name: UCB4940

Other: Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.

Experimental: Bimekizumab dosing regimen 5 Drug: Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Other Name: UCB4940




Primary Outcome Measures :
  1. Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 [ Time Frame: Week 12 ]
    The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.


Secondary Outcome Measures :
  1. Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12 [ Time Frame: Week 12 ]
    The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.

  2. Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8 [ Time Frame: Week 8 ]
    The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.

  3. Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8 [ Time Frame: Week 8 ]
    The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

  4. Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12 [ Time Frame: Week 12 ]
    The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

  5. Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 [ Time Frame: Week 12 ]
    PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 12 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 12.

  6. Plasma Concentrations of Bimekizumab During the Study [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]

    Bimekizumab plasma concentration was expressed in micrograms per milliliter (μg/mL).

    Values Below Limit of Quantification (BLQ) were replaced by the value of lower limit of quantification (LLOQ) divided by 2 = 0.075 μg/mL in the calculations of geometric mean and confidence intervals (CIs). Geometric mean was only calculated if at least two-thirds of the concentrations were quantified at the respective time point.


  7. Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab [ Time Frame: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28) ]

    The data were presented as population estimates of CL/F. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group.

    It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.


  8. Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab [ Time Frame: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28) ]

    The data were presented as population estimates of V/F. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group.

    It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.


  9. Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50) [ Time Frame: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28) ]

    The data were presented as population estimates of EC50. EC50 was estimated based on all available data and cannot be derived for each treatment arm.

    It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.


  10. Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment [ Time Frame: Baseline (Week 0) ]
    Antibody positive status prior study treatment was defined as having an antibody level greater than (>) 28.5% at Baseline (Week 0).

  11. Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment [ Time Frame: From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28) ]
    Overall antibody positive was defined as having a value of > 28.5% at any time in the Treatment Period. The Treatment Period did not include Baseline/pretreatment samples.

  12. Percentage of Participants With at Least One Adverse Event (AE) During the Study [ Time Frame: From Screening to End of Safety Follow-up (up to Week 32) ]
    An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.

  13. Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity [ Time Frame: From Screening to End of Safety Follow-up (up to Week 32) ]
    An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.

  14. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Platelets was measured in number of platelets per liter (10^9/L).

  15. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).

  16. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).

  17. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Erythrocytes mean corpuscular volume was measured in femtolitres (fL).

  18. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Erythrocytes was measured in number of red blood cells per liter (10^12/L).

  19. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Hematocrit was measured in volume percentage (%) of red blood cells in blood.

  20. Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).

  21. Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).

  22. Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase were measured in units per liter (U/L).

  23. Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Creatinine and bilirubin were measured in micromols per liter (μmol/L).

  24. Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    C Reactive Protein was measured in milligrams per liters (mg/L).

  25. Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Urine pH was measured on a pH scale.

  26. Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) [ Time Frame: From Baseline (Week 0) until Week 12 ]
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.

  27. Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) [ Time Frame: From Baseline (Week 0) until Week 12 ]
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.

  28. Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) [ Time Frame: From Baseline (Week 0) until Week 12 ]
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.

  29. Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) [ Time Frame: From Baseline (Week 0) until Week 12 ]
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.

  30. Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) [ Time Frame: From Baseline (Week 0) until Week 12 ]
    Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.

  31. Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Blood pressure was measured in millimeters of mercury (mmHg).

  32. Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Pulse rate was measured in beats per minute (beats/min).

  33. Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) [ Time Frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Temperature was measured in degrees Celsius (°C).

  34. Percentage of Participants With Clinically Significant Physical Examination Abnormalities [ Time Frame: At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose) ]

    The physical examination included general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; CV; GI; musculoskeletal; hepatic; neurological (including limb reflexes); and mental status.

    Any clinically significant abnormal findings during the study were captured as adverse events.


  35. Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings [ Time Frame: Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) ]
    Percentages were based on the number of participants with a non-missing measurement for that variable at the visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided informed consent
  • Chronic plaque psoriasis for at least 6 months prior to Screening
  • PASI (Psoriasis Area and Severity Index) >=12 and BSA (body surface area) >=10% and IGA (Investigator's Global Assessment) score 3 or greater on a 5-point scale
  • Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
  • 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
  • Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication

Exclusion Criteria:

  • Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
  • Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease
  • Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
  • Subject taking prohibited psoriatic medications
  • Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug administration
  • Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17) therapy or has been exposed to more than 1 biological response modifier (limited to anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline
  • Subject has any current sign or symptom that may indicate an active infection (except for common cold)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905006


Locations
Show Show 41 study locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Parexel
Investigators
Layout table for investigator information
Study Director: UCB Cares +1 844 599 2273 (UCB)
  Study Documents (Full-Text)

Documents provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Study Protocol  [PDF] July 18, 2016
Statistical Analysis Plan  [PDF] June 13, 2017

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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT02905006    
Other Study ID Numbers: PS0010
2016-001891-31 ( EudraCT Number )
First Posted: September 19, 2016    Key Record Dates
Results First Posted: November 19, 2020
Last Update Posted: November 19, 2020
Last Verified: November 2020
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Psoriasis
Chronic Plaque Psoriasis
Bimekizumab
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases