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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1118-2792 | Other Identifier | WHO |
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Trial discontinued due to apparent lack of response in psoriasis measures. No safety concerns were present
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This trial is conducted in the United States of America (USA). The aim of this clinical trial is evaluate the safety and tolerability of anti-IL-20 in patients with psoriasis and to determine the preliminary efficacy in an expansion phase of this trial.
This trial consists of 3 parts: A single dose (SD) dose-escalation phase for 16 weeks, a multiple dose (MD) dose-escalation phase for 22 weeks, and a MD expansion phase for 22 weeks.
Initiation of the MD expansion phase will depend on results from the SD and MD dose-escalation phases and only if an acceptable safety profile is present. Subjects participating in the expansion phase are not allowed to have participated in the previous phases (SD and MD dose-escalation phases) of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-IL-20 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-IL-20 | Drug | Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - SD phase | from week 0 until end of trial observation period at week 16 | |
| Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD and MD expansion phases | from week 0 until end of trial observation period at week 22 | |
| Improvement psoriasis area and severity index score by 75% (PASI75) - MD expansion phase | at weeks 1-7, 9-15, 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD expansion phase | from week 0 until end of trial observation period at week 22 | |
| Improvement psoriasis area and severity index score by 75% (PASI75) - SD and MD phases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Birmingham | Alabama | 35294 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25749867 | Result | Lundblad MS, Overgaard RV, Gothberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7. | |
| 26252485 | Derived |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo |
| Drug |
Placebo for subcutaneous (under the skin) injection |
|
| SD: at weeks 1, 3, 9, 13 and 16. MD: at weeks 1, 3, 5, 7, 9, 15, 22 |
| Pharmacokinetics (the rate at which the body eliminates the trial drug) - SD and MD phases | SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7) |
| Pharmacokinetics (the rate at which the body eliminates the trial drug) - MD expansion phase | prior to dosing (week 1) and at each dosing visit (week 2-7) |
| Pharmacodynamics (the effect of the investigated drug on the body) - SD and MD phases | SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7) |
| Pharmacodynamics (the effect of the investigated drug on the body) - MD expansion phase | prior to dosing (week 1) and at each dosing visit (week 2-7) |
| Los Angeles |
| California |
| 90036 |
| United States |
| Novo Nordisk Investigational Site | Skokie | Illinois | 60077 | United States |
| Novo Nordisk Investigational Site | Indianapolis | Indiana | 46256-4697 | United States |
| Novo Nordisk Investigational Site | Baltimore | Maryland | 21225 | United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02111-1526 | United States |
| Novo Nordisk Investigational Site | St Louis | Missouri | 63117-1206 | United States |
| Novo Nordisk Investigational Site | New Brunswick | New Jersey | 08903 | United States |
| Novo Nordisk Investigational Site | New York | New York | 10010 | United States |
| Novo Nordisk Investigational Site | New York | New York | 10029 | United States |
| Novo Nordisk Investigational Site | Winston-Salem | North Carolina | 27157 | United States |
| Novo Nordisk Investigational Site | Portland | Oregon | 97210-5102 | United States |
| Novo Nordisk Investigational Site | Portland | Oregon | 97239-4501 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75246 | United States |
| Novo Nordisk Investigational Site | Salt Lake City | Utah | 84132-0002 | United States |
| Novo Nordisk Investigational Site | Norfolk | Virginia | 23507-1970 | United States |
| Gottlieb AB, Krueger JG, Sandberg Lundblad M, Gothberg M, Skolnick BE. First-In-Human, Phase 1, Randomized, Dose-Escalation Trial with Recombinant Anti-IL-20 Monoclonal Antibody in Patients with Psoriasis. PLoS One. 2015 Aug 7;10(8):e0134703. doi: 10.1371/journal.pone.0134703. eCollection 2015. |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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