BE COMPLETE: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Study Details
Study Description
Brief Summary
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bimekzumab dosage regimen Subjects randomized to this arm will receive assigned bimekizumab dosage regimen. |
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Names:
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| Placebo Comparator: Placebo Subjects randomized to this arm will receive placebo. |
Other: Placebo
Subjects will receive placebo at pre-specified time-points.
Other Names:
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Outcome Measures
Primary Outcome Measures
- American College of Rheumatology (ACR) 50 response at Week 16 [Week 16]
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.
Secondary Outcome Measures
- Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 [Baseline, Week 16]
HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicates an improvement.
- Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline [Baseline, Week 4]
The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline. The PASI 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.
- Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline [Baseline, Week 16]
The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline. The PASI 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.
- Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) score at Week 16 [Baseline, Week 16]
There are 8 SF-36 domain scores. In addition to domain scores, 2 component summary (PCS and MCS) scores are calculated from the 8 domains. These are norm-based T-scores standardized with a mean of 50 and a standard deviation (SD) of 10, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
- Minimal Disease Activity (MDA) at Week 16 [Week 16]
Minimal Disease Activity (MDA) is a state of disease activity deemed a useful target of treatment by both the patient and physician, given current treatment possibilities and limitations. Criteria covering all domains of the disease have been developed to determine whether or not a patient has reached MDA based on key outcome measures in Psoriatic Arthritis (PsA). A subject is considered as having MDA if 5 or more of the following 7 criteria are fulfilled: 1) Tender joint count <=1, 2) Swollen joint count <=1, 3) PASI <=1 or BSA <=3; 4) Patient pain Visual Analog Scale (VAS) <=15, 5) Patient global activity VAS <=20, 6) Health Assessment Questionnaire - Disability Index (HAQ-DI) <=0.5 and 7) Tender enthesial points <=1.
- American College of Rheumatology (ACR) 20 response at Week 16 [Week 16]
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline.
- American College of Rheumatology (ACR) 70 response at Week 16 [Week 16]
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline.
- Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 4 in the subset of subjects with psoriatic skin lesions at Baseline [Baseline, Week 4]
Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
- Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of subjects with psoriatic skin lesions at Baseline [Baseline, Week 16]
Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
- Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16 [Baseline, Week 16]
The PtAAP Visual Analog Scale (VAS) or 'Pain VAS' is part of the American College of Rheumatology (ACR) core set of measures in arthritis. Subjects will assess their arthritis pain using a VAS where 0 is "no pain" and 100 is "most severe pain."
- Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) total score at Week 16 [Baseline, Week 16]
The PsAID-12 total score is a patient-reported outcome measure for assessing the impact of Psoriatic Arthritis (PsA) in 12 physical and psychological domains, including pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear/uncertainty, embarrassment and/or shame, social participation, and depression. Each domain is assessed with a single question using a 0 to 10 numerical rating scale. Each domain score is multiplied by a weighting factor and the results are then summed to provide the total score. The total score ranges from 0 to 10, with higher scores indicating a worse status. A score below 4 out of 10 is considered a patient-acceptable status. A change of 3 or more points is considered relevant absolute change.
- Incidence of treatment-emergent adverse events (TEAEs) during the study [From Baseline until Safety Follow-Up (up to Week 36)]
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
- Incidence of treatment-emergent serious adverse events (SAEs) during the study [From Baseline until Safety Follow-Up (up to Week 36)]
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Is an infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
- Treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study [From Baseline until Safety Follow-Up (up to Week 36)]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is male or female at least 18 years of age
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Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
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Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
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Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
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Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
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Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO
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Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
Exclusion Criteria:
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Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
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Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
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Subject has an active infection or a history of recent serious infections
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Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
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Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
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Subject had acute anterior uveitis within 6 weeks of Baseline
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Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
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Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
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Presence of active suicidal ideation, or moderately severe major depression or severe major depression
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Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pa0011 50017 | Phoenix | Arizona | United States | 85037 |
| 2 | Pa0011 50035 | San Diego | California | United States | 92025 |
| 3 | Pa0011 50004 | Tustin | California | United States | 92780 |
| 4 | Pa0011 50033 | Palm Harbor | Florida | United States | 34684-3176 |
| 5 | Pa0011 50037 | Tampa | Florida | United States | 33613 |
| 6 | Pa0011 50039 | Atlanta | Georgia | United States | 30342 |
| 7 | Pa0011 50024 | Boise | Idaho | United States | 83702 |
| 8 | Pa0011 50028 | Lexington | Kentucky | United States | 40504 |
| 9 | Pa0011 50023 | Baton Rouge | Louisiana | United States | 70836 |
| 10 | Pa0011 50015 | Hagerstown | Maryland | United States | 21742 |
| 11 | Pa0011 50026 | Wheaton | Maryland | United States | 20902 |
| 12 | Pa0011 50047 | Boston | Massachusetts | United States | 02115 |
| 13 | Pa0011 50019 | Lansing | Michigan | United States | 48910 |
| 14 | Pa0011 50001 | Saint Louis | Missouri | United States | 63141 |
| 15 | Pa0011 50016 | Saint Louis | Missouri | United States | 63141 |
| 16 | Pa0011 50005 | Freehold | New Jersey | United States | 07728 |
| 17 | Pa0011 50029 | Albuquerque | New Mexico | United States | 87102 |
| 18 | Pa0011 50010 | Brooklyn | New York | United States | 11201 |
| 19 | Pa0011 50011 | New York | New York | United States | 10029 |
| 20 | Pa0011 50034 | Rochester | New York | United States | 14642 |
| 21 | Pa0011 50125 | Charlotte | North Carolina | United States | 28210 |
| 22 | Pa0011 50031 | Salisbury | North Carolina | United States | 28144 |
| 23 | Pa0011 50040 | Dayton | Ohio | United States | 45417 |
| 24 | Pa0011 50020 | Duncansville | Pennsylvania | United States | 16635 |
| 25 | Pa0011 50064 | Philadelphia | Pennsylvania | United States | 19104 |
| 26 | Pa0011 50006 | Wyomissing | Pennsylvania | United States | 19610 |
| 27 | Pa0011 50008 | Johnston | Rhode Island | United States | 02919 |
| 28 | Pa0011 50021 | Summerville | South Carolina | United States | 29486 |
| 29 | Pa0011 50012 | Memphis | Tennessee | United States | 38119 |
| 30 | Pa0011 50002 | Austin | Texas | United States | 78731 |
| 31 | Pa0011 50036 | Mesquite | Texas | United States | 75150 |
| 32 | Pa0011 50009 | Waco | Texas | United States | 76710 |
| 33 | Pa0011 50050 | Beckley | West Virginia | United States | 25801 |
| 34 | Pa0011 30005 | Camberwell | Australia | ||
| 35 | Pa0011 30007 | Victoria Park | Australia | ||
| 36 | Pa0011 30006 | Woodville | Australia | ||
| 37 | Pa0011 50042 | Rimouski | Canada | ||
| 38 | Pa0011 50043 | Sydney | Canada | ||
| 39 | Pa0011 50044 | Trois-Rivières | Canada | ||
| 40 | Pa0011 40009 | Pardubice | Czechia | ||
| 41 | Pa0011 40066 | Praha 2 | Czechia | ||
| 42 | Pa0011 40063 | Praha 5 | Czechia | ||
| 43 | Pa0011 40012 | Zlín | Czechia | ||
| 44 | Pa0011 40076 | Cottbus | Germany | ||
| 45 | Pa0011 40023 | Erlangen | Germany | ||
| 46 | Pa0011 40117 | Frankfurt | Germany | ||
| 47 | Pa0011 40029 | Hamburg | Germany | ||
| 48 | Pa0011 40071 | Hamburg | Germany | ||
| 49 | Pa0011 40078 | Leipzig | Germany | ||
| 50 | Pa0011 40026 | Ratingen | Germany | ||
| 51 | Pa0011 40083 | Budapest | Hungary | ||
| 52 | Pa0011 40079 | Szentes | Hungary | ||
| 53 | Pa0011 40084 | Catania | Italy | ||
| 54 | Pa0011 40087 | Milano | Italy | ||
| 55 | Pa0011 40086 | Reggio Emilia | Italy | ||
| 56 | Pa0011 20043 | Itabashi-Ku | Japan | ||
| 57 | Pa0011 20036 | Kawachi-Nagano | Japan | ||
| 58 | Pa0011 20045 | Kita-Gun | Japan | ||
| 59 | Pa0011 20049 | Kitakyushu | Japan | ||
| 60 | Pa0011 20044 | Minato-Ku | Japan | ||
| 61 | Pa0011 20041 | Osaka | Japan | ||
| 62 | Pa0011 20046 | Osaka | Japan | ||
| 63 | Pa0011 20048 | Saitama | Japan | ||
| 64 | Pa0011 20031 | Sapporo-City | Japan | ||
| 65 | Pa0011 20042 | Sasebo | Japan | ||
| 66 | Pa0011 20032 | Suita | Japan | ||
| 67 | Pa0011 20030 | Tokyo | Japan | ||
| 68 | Pa0011 40119 | Bydgoszcz | Poland | ||
| 69 | Pa0011 40038 | Elbląg | Poland | ||
| 70 | Pa0011 40037 | Lublin | Poland | ||
| 71 | Pa0011 40091 | Nowa Sól | Poland | ||
| 72 | Pa0011 40044 | Poznań | Poland | ||
| 73 | Pa0011 40090 | Poznań | Poland | ||
| 74 | Pa0011 40118 | Toruń | Poland | ||
| 75 | Pa0011 40041 | Warszawa | Poland | ||
| 76 | Pa0011 40097 | Warszawa | Poland | ||
| 77 | Pa0011 40098 | Warszawa | Poland | ||
| 78 | Pa0011 40039 | Wrocław | Poland | ||
| 79 | Pa0011 40043 | Wrocław | Poland | ||
| 80 | Pa0011 20005 | Moscow | Russian Federation | ||
| 81 | Pa0011 20010 | Moscow | Russian Federation | ||
| 82 | Pa0011 20013 | Petrozavodsk | Russian Federation | ||
| 83 | Pa0011 20001 | Saint Petersburg | Russian Federation | ||
| 84 | Pa0011 20004 | Saint Petersburg | Russian Federation | ||
| 85 | Pa0011 20009 | Saint Petersburg | Russian Federation | ||
| 86 | Pa0011 20007 | Saratov | Russian Federation | ||
| 87 | Pa0011 20014 | Ulyanovsk | Russian Federation | ||
| 88 | Pa0011 20006 | Vladimir | Russian Federation | ||
| 89 | Pa0011 20008 | Yaroslavl | Russian Federation | ||
| 90 | Pa0011 20015 | Yaroslavl | Russian Federation | ||
| 91 | Pa0011 40111 | Bradford | United Kingdom | ||
| 92 | Pa0011 40109 | Oxford | United Kingdom | ||
| 93 | Pa0011 40116 | Stamford | United Kingdom |
Sponsors and Collaborators
- UCB Biopharma SRL
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PA0011
- 2017-002804-29