Trial record 1 of 1 for:
NCT03347110
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis (BE ACTIVE 2)
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| ClinicalTrials.gov Identifier: NCT03347110 |
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Recruitment Status :
Completed
First Posted : November 20, 2017
Last Update Posted : April 3, 2023
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Sponsor:
UCB Biopharma SRL
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )
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Brief Summary:
This is a study to assess the long-term safety and tolerability of bimekizumab in subjects with psoriatic arthritis
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriatic Arthritis | Drug: Bimekizumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 184 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis |
| Actual Study Start Date : | November 22, 2017 |
| Actual Primary Completion Date : | October 29, 2020 |
| Actual Study Completion Date : | October 29, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Psoriatic arthritis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Bimekizumab
Subjects will receive bimekizumab up to 2 years.
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Drug: Bimekizumab
Bimekizumab at a prespecified dose.
Other Name: UCB4940 |
Primary Outcome Measures :
- Incidence of treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120) ]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 [ Time Frame: From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120) ]Once it is determined that a subject experienced an adverse event (AE), the seriousness of the AE must be determined. An SAE must meet 1 or more of the following criteria: death, life-threatening, significant or persistent disability/incapacity, congenital anomaly/birth defect, important medical event, initial inpatient hospitalization or prolongation of hospitalization.) product.
Secondary Outcome Measures :
- Subjects who withdrew due to an treatment-emergent adverse event (TEAE) during the study [ Time Frame: From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120) ]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.
- ACR20 (American College of Rheumatology 20% Improvement) Response at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: Baseline of PA0008, Week 48 ]The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline of PA0008.
- ACR50 (American College of Rheumatology 50% Improvement) Response at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: Baseline of PA0008, Week 48 ]The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline of PA0008.
- ACR70 (American College of Rheumatology 70% Improvement) Response at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: Baseline of PA0008, Week 48 ]The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline of PA0008.
- Change from Baseline of PA0008 in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: Baseline of PA0008, Week 48 ]The MASES is an index that measures the severity (ie, intensity and extent) of enthesitis through the assessment of 13 entheses each scored as 0 or 1 and then summed for a possible score of 0 to 13.
- Change from Baseline of PA0008 in the Leeds Dactylitis Index (LDI) at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: Baseline of PA0008, Week 48 ]Presence of dactylitis will be assessed using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present).
- PASI75 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: Baseline of PA0008, Week 48 ]
The PASI75 response is based on at least 75% improvement in the PASI score compared to Baseline in PA0008.
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
- PASI90 (Psoriasis Area Severity Index) Response at Week 48 calculated relative to Baseline of PA0008 [ Time Frame: Baseline of PA0008, Week 48 ]
The PASI90 response is based on at least 90% improvement in the PASI score compared to Baseline in PA0008.
The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5-point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
- Subject completed PA0008 without meeting any withdrawal criteria
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active
Exclusion Criteria:
- Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of IMP. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
- Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
- Subjects who meet any withdrawal criteria in PA0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into PA0009
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): NCT03347110
Locations
Show 37 study locations
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
| Study Director: | UCB Cares | +1 8445992273 (UCB) |
Publications of Results:
| Responsible Party: | UCB Biopharma SRL |
| ClinicalTrials.gov Identifier: | NCT03347110 |
| Other Study ID Numbers: |
PA0009 2017-001003-74 ( EudraCT Number ) |
| First Posted: | November 20, 2017 Key Record Dates |
| Last Update Posted: | April 3, 2023 |
| Last Verified: | March 2023 |
| 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.: | No |
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
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Bimekizumab Psoriatic Arthritis PsA |
Additional relevant MeSH terms:
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Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis |
Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases |