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Patients with plaque psoriasis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Single 0.3 | Experimental |
| |
| Repeat 1.0 | Experimental |
| |
| Repeat 2.0 | Experimental |
| |
| Repeat 4.0 | Experimental |
| |
| Repeat 8.0 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTT1023 | Drug | intravenous, three infusions over three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 12 weeks | |
| Plasma concentrations of BTT1023 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Psoriasis Area and Severity Index (PASI) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotie investigational site | Dresden | Dresden | 01067 | Germany | ||
| Biotie investigational site |
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| ID | Term |
|---|---|
| C000627434 | timolumab |
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| Placebo | Drug | intravenous, three infusions over three weeks |
|
| BTT1023 | Drug | Test challenge |
|
| Leipzig |
| Leipzig |
| 04103 |
| Germany |
| Biotie investigational site | Berlin | State of Berlin | 12627 | Germany |
| Biotie investigational site | Berlin | State of Berlin | 14050 | Germany |
| Biotie Investigational Site | Görlitz | 02826 | Germany |