AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/6/2018 |
Start Date: | May 11, 2010 |
End Date: | October 18, 2016 |
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.
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.
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.
Key Inclusion Criteria:
- Patients who completed the core study CAIN457A2211. A patient is defined as having
completed the core study if he/she completed the study up to and including visit 13
(F4) of the core study
- Patients must be able to understand and communicate with the investigator and comply
with the requirement of the study and must given written, signed and dated informed
consent before any study assessment is performed.
- Patients must be expected to benefit from the ongoing treatment with AIN457, as
assessed by the patient and investigator
- Male patients must consent to practice reliable contraception during the study and for
16 weeks after the last dose of study drug administration Note: Due to new data
available from the toxicology studies, the need for male contraception was removed.
Key Exclusion Criteria:
- Patients who experience a second consecutive full relapse at visit 13 ( week F4) of
the core study CAIN457A2211
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until termination of gestation, confirmed by a positive
hCG laboratory test (> 5mlU/mL)
- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unwilling to use effective contraception during the study and for
16 weeks after stopping treatment.
We found this trial at
25
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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