Phase 3 N=995 Randomized Double-blind Treatment

Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

Moderate to Severe Plaque-type Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT01544595 ↗

Enrolled (actual)

995

Serious AEs

14.5%

Results posted

Dec 2018

Primary outcome: Primary: Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 — 49.8; 25.4; 74.3; 64.7 Cummulative rate — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Secukinumab (AIN457) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68	49.8; 25.4; 74.3; 64.7	<0.0001 sig
SECONDARY Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period	208; 309; 112; 157; 297; 363	—
SECONDARY Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period	164; 416; 121; 361; 85; 303	—
SECONDARY Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period	-92.31; -95.98; -92.88; -96.16; -85.88; -91.51	—
SECONDARY Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period	-85.93; -91.82; -85.97; -88.86; -93.03; -87.78	—
SECONDARY Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period	95; 188; 56; 94; 113; 121	—
SECONDARY Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period	56; 188; 38; 123; 44; 71	—
SECONDARY Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period	94; 311; 63; 239; 50; 206	—
SECONDARY Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period	38.1; 33.4; 82.1; 65.5	—
SECONDARY Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse	38.5; 51.0; 91.2; 95.1; 96.8; 98.8	—
SECONDARY Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse	12.5; 28.1; 75.0; 83.5; 87.9; 90.8	—
SECONDARY Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period	0.3; 0.3; 0.0; 0.0; 3.1; 2.2	—
SECONDARY Percent of Participants With Relapse After Last Injection	7.2; 2.0; 34.0; 28.4	—
SECONDARY Percent of Participants With Rebound After Last Injection	8.3; 6.6; 11.8; 9.5	—
SECONDARY Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data)	196; 281; 109; 142; 170; 265	—
SECONDARY Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period	95; 299; 66; 254; 47; 225	—
SECONDARY EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period	0.03; 2.09; -9.58; -5.57; 0.79; 2.76	—
SECONDARY EQ-5D Health State Assessment (Observed Value) - Entire Study Period	-1.33; 1.44; -1.99; 2.10; -0.66; 1.45	—
SECONDARY Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period	7.0; 4.9; 7.2; 8.6; 1.4; 0.8	—
SECONDARY Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period	55; 59; 114; 10; 7; 17	—
SECONDARY Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period	10.5; 9.4; 11.3; 14.1; 0.7; 1.1	—
SECONDARY Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period	1; 2; 3; 8; 23; 30	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01544595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.