Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002086-35 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB4940 8 mg | Experimental | Single intravenous (iv) infusion of UCB4940 8 mg over at least 60 minutes. |
|
| UCB4940 40 mg | Experimental | Single intravenous (iv) infusion of UCB4940 40 mg over at least 60 minutes. |
|
| UCB4940 160 mg | Experimental | Single intravenous (iv) infusion of UCB4940 160 mg over at least 60 minutes. |
|
| UCB4940 480 mg | Experimental | Single intravenous (iv) infusion of UCB4940 480 mg over at least 60 minutes. |
|
| UCB4940 640 mg | Experimental | Single intravenous (iv) infusion of UCB4940 640 mg over at least 60 minutes. |
|
| Placebo | Placebo Comparator | Single intravenous (iv) infusion of Placebo over at least 60 minutes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB4940 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) | Baseline to 20 Weeks | |
| Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) | Baseline to 20 Weeks | |
| Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) | Baseline to 20 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 | |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-inf)) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
Not provided
Inclusion criteria:
Exclusion Criteria:
Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method
Subject has received systemic nonbiologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening
Subject has received treatment with biologic agents within 12 months prior to the study
Subject has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study
Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to IMP administration
Subject requires treatment with a nonsteroidal anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic
Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration. When in doubt, the Investigator should confer with the UCB Study Physician
Subject has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening that cannot be attributed to a prior Bacillus Calmette-Guérin inoculation
Subject has renal or liver impairment, defined as:
Subject has active neoplastic disease or history of neoplastic disease within 5 years of Screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 8229493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 | Harrow | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27859546 | Derived | Glatt S, Helmer E, Haier B, Strimenopoulou F, Price G, Vajjah P, Harari OA, Lambert J, Shaw S. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017 May;83(5):991-1001. doi: 10.1111/bcp.13185. Epub 2017 Jan 10. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625981 | bimekizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other |
|
|
| Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC(0-t)) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| Time to reach Cmax (Tmax) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| Terminal elimination half-life (t1/2) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| First order terminal elimination rate constant (λz) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| Total body clearance (CL) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| Volume of distribution in terminal phase (Vz) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| Percentage Change from Baseline to Week 12 in the Lesion Severity Score (LSS) | Baseline to Week 12 |
| Percentage Change from Baseline to Week 12 in thickness of the plaque | Baseline to Week 12 |
| Percentage Change from Baseline to Week 12 in lesion area | Baseline to Week 12 |
| Percentage Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI) | Baseline to Week 12 |
| Percentage Change from Baseline to Week 12 in Physician's Global Assessment (PGA) | Baseline to Week 12 |