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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004949-16 | EudraCT Number |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
| MAC Clinical Research | OTHER |
| Comac Medical | INDUSTRY |
| ARENSIA, Moldova |
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A study of UCB4940 in subjects with psoriatic arthritis to evaluate the safety and body distribution of UCB4940 in those patients. Neither the patient nor the doctor will know the treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 240/160/160 mg of UCB4940 | Experimental | 240 mg loading dose + 160 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses) |
|
| 160/80/80 mg of UCB4940 | Experimental | 160 mg loading dose + 80 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses) |
|
| 80/40/40 mg of UCB4940 | Experimental | 80 mg loading dose + 40 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses) |
|
| 560/320/320 mg of UCB4940 | Experimental | 560 mg loading dose + 320 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses) |
|
| Placebo | Placebo Comparator | 0.9% sodium chloride aqueous solution (physiological saline, preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 10 mL glass vial |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB4940 40 mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration at steady state (CmaxSS) of UCB 4940 during the duration of the study (up to Day 141) |
| From Baseline to Day 141 |
| Minimum plasma concentration at steady state (CminSS) of UCB4940 during the duration of the study (up to Day 141) |
| From Baseline to Day 141 |
| Area under the curve at steady state (AUCtau) of UCB4940 during the duration of the study (up to Day 141) |
| From Baseline to Day 141 |
| Time to reach maximum plasma concentration at steady state (tmax) of UCB4940 during the duration of the study (up to Day 141) |
| From Baseline to Day 141 |
| Total Clearance (CL) of UCB4940 during the duration of the study (up to Day 141) |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 001 | Sofia | Bulgaria | ||||
| 002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29275332 | Derived | Glatt S, Baeten D, Baker T, Griffiths M, Ionescu L, Lawson ADG, Maroof A, Oliver R, Popa S, Strimenopoulou F, Vajjah P, Watling MIL, Yeremenko N, Miossec P, Shaw S. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018 Apr;77(4):523-532. doi: 10.1136/annrheumdis-2017-212127. Epub 2017 Dec 23. |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| C000625981 | bimekizumab |
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| UCB4940 80 mg | Drug |
|
|
| UCB4940 160 mg | Drug |
|
|
| UCB4940 240 mg | Drug |
|
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| UCB4940 320 mg | Drug |
|
|
| UCB4940 560 mg | Drug |
|
|
| Placebo | Other |
|
|
| From Baseline to Day 141 |
| Volume of distribution (V) of UCB4940 during the duration of the study (up to Day 141) |
| From Baseline to Day 141 |
| Percentage of subjects with at least one Treatment Emergent Adverse Event (TEAE) during the study | From Baseline to Day 141 |
| Saint Chisinau |
| Moldova |
| 003 | Manchester | United Kingdom |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |