Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects
NCT ID: NCT02156466
Last Updated: 2017-01-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2014-08-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MSB0010841 30 mg
MSB0010841
MSB0010841(Anti- IL-17A/F Nanobody) will be administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
MSB0010841 60 mg
MSB0010841
MSB0010841 will be administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
MSB0010841 120 mg
MSB0010841
MSB0010841 will be administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
MSB0010841 240 mg
MSB0010841
MSB0010841 will be administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
Placebo
Placebo
Placebo matched to MSB0010841 will be administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
Interventions
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MSB0010841
MSB0010841(Anti- IL-17A/F Nanobody) will be administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
MSB0010841
MSB0010841 will be administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
MSB0010841
MSB0010841 will be administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
MSB0010841
MSB0010841 will be administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
Placebo
Placebo matched to MSB0010841 will be administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Greater than or equal to (\>=) 10% of BSA with plaques
* Psoriasis Area and Severity Index (PASI) \>=12
* Static Physician's Global Assessment (sPGA) \>=3 (where scores range from 0 \[clear of disease\] to 5 \[severe disease\]) at the screening and baseline visits
Exclusion Criteria
* Currently having a form of non-plaque psoriasis as specified in the protocol
* Drug induced psoriasis
* Biological treatments as specified in the protocol, within 3 months prior to Day 1
* Systemic immunosuppressants or phototherapy as specified in the protocol, within 1 month prior to Day 1
* Use of anti-coagulant medications and/or antiplatelet medications as defined in the protocol
* Use of aspirin as defined in the protocol
* Topical corticosteroid treatments other than low-strength or lower-mid strength corticosteroids on the face, scalp, axillae, and/or groin within 1 month prior to Day 1
* Any previous treatment with an agent targeting interleukin (IL)-17, IL-12 and/or IL-23 as specified in the protocol
18 Years
70 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Please contact the Merck KGaA Communication Center
Darmstadt, , Germany
Countries
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Other Identifiers
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2013-005436-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
200574-003
Identifier Type: -
Identifier Source: org_study_id
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