Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/22/2018 |
Start Date: | June 19, 2012 |
End Date: | June 26, 2017 |
A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 4 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
This was an extension study of secukinumab prefilled syringes in subjects with moderate to
severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with
secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies
(e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III
studies) were eligible to join this extension study. This extension study was planned to
collect an additional 2 years of long-term efficacy, safety, and tolerability data of
secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in
subjects showing at least partial response to secukinumab and completing treatment period on
secukinumab in previous phase III studies. In this extension study, the prefilled syringe
(PFS) liquid formulation of secukinumab were used.
severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with
secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies
(e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III
studies) were eligible to join this extension study. This extension study was planned to
collect an additional 2 years of long-term efficacy, safety, and tolerability data of
secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in
subjects showing at least partial response to secukinumab and completing treatment period on
secukinumab in previous phase III studies. In this extension study, the prefilled syringe
(PFS) liquid formulation of secukinumab were used.
Key Inclusion Criteria:
Completed the full study treatment period of 52 weeks in preceding phase III studies, and
have been receiving secukinumab treatment during the maintenance phase of the preceding
phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of
the preceding phase III studies.
Written informed consent form.
Key Exclusion Criteria:
A protocol deviation in either of the preceding phase III studies which according to the
investigator prevented the meaningful analysis of the extension study for the individual
subject.
Ongoing use of prohibited psoriasis or non-psoriasis treatments.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
after conception and until the termination of gestation, confirmed by a positive hCG
laboratory test (>10 mIU/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
40
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
Click here to add this to my saved trials
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
Click here to add this to my saved trials
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials