Plaque-type Psoriasis Clinical Trial
Official title:
A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Participants With Moderate to Severe Chronic Plaque-type Psoriasis
The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.
In the Proof-of-Concept study (CAIN457A2102/ NCT00669916), AIN457 was proven to be
efficacious in the treatment of moderate to severe chronic plaque-type psoriasis. As a
result, a phase IIb regimen finding study had been started (CAIN457A2211/NCT00941031).
The data gathered in this extension study of the core study (CAIN457A2211)was used to expand
the safety database of the compound for the treatment of moderate to severe chronic
plaque-type psoriasis. The participants in the extension study continued to stay on the exact
same treatment regimen they were taking when completing the core study. The extension trial
was first designed to provide long-term safety data of up to 100 weeks of treatment (32 weeks
in the core study plus 68 weeks in the extension study (part 1)), and an additional 12 weeks
of treatment-free follow-up for participants who did not continue in the extension study.
Amendment 2 provided an additional 156 weeks of treatment (32 weeks in the core study plus
224 weeks in the extension study, equaling 256 weeks of total treatment (part 2)), before
participants entered the 12 weeks of treatment-free follow-up. Protocol Amendment 3 extended
the prolongation part of the study by up to 104 additional weeks of treatment (part 3) or
until the drug was commercially available in the market of the country of participation,
whichever occurred first.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT01936688 -
A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous MK-3222 in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-012)
|
Phase 3 | |
| Completed |
NCT00763503 -
Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CD 2027 Spray in Adults With Plaque-type Psoriasis
|
Phase 2 | |
| Completed |
NCT00773734 -
Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)
|
Phase 2 | |
| Completed |
NCT01636687 -
Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
|
Phase 3 | |
| Completed |
NCT01258088 -
Safety Study of Ointment for the Treatment of Plaque-type Psoriasis
|
Phase 1 | |
| Completed |
NCT00852761 -
A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis
|
Phase 4 | |
| Completed |
NCT00625326 -
Study of Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis
|
Phase 2 | |
| Completed |
NCT01412944 -
Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis
|
Phase 3 | |
| Completed |
NCT00521339 -
Apremilast Safety and PK Study in Recalcitrant Plaque Psoriasis
|
Phase 2 | |
| Completed |
NCT01876875 -
n-3 Polysaturated Fatty Acids-rich Diet in Psoriasis
|
Phase 4 |