PARAMETER

DATA

Manufacturer

Novartis Pharmaceuticals Corporation

Indication

COSENTYX is a human interleukin-IL-17A antagonist indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Cell Substrate

CHO (Chinese Hamster Ovary) cells MCB 060428 (CHO-HPT1 cell line)

Manufacturing platform

The cell culture process is conventional, expanding the culture via T-flasks and roller bottles to a fed batch bioreactor. The cell culture media used for inoculum preparation, for seed expansion, and for the production stage are serum-free, with low protein content and do not contain animal- or human-derived raw materials. The cell culture fluid is harvested as a single-harvest batch which is subsequently purified as a single active substance batch. The purification process consists of 9 steps including harvest, chromatography and filtration with final freezing and storage at ≤- 60̊C.

Dose in vial/final container

• Injection: 150 mg/mL solution in a single-use Sensoready® pen
• Injection: 150 mg/mL solution in a single-use prefilled syringe
• For Injection: 150 mg, lyophilized powder in a single-use vial for reconstitution.

Dose to patient

300 mg by subcutaneous injection at Weeks 0, 1, 2, 3 and 4 followed by 300 mg every 4 weeks. Each 300 mg dose is given as 2 subcutaneous injections of 150 mg.

NCT

TRIAL PHASE

NO OF PATIENTS ENROLLED

TITLE

COUNTRIES

Placebo-controlled, active-controlled trials

NCT01365455

3

738

Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year

United States, Canada, Estonia, Colombia, Japan, Iceland, Israel, Latvia, Argentina, Lithuania, Taiwan, Mexico

NCT01358578

3

1306

Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects with Moderate to Severe, Chronic Plaque-Type Psoriasis

United States, Argentina, Italy, Australia, Belgium, Canada, Colombia, Egypt, Finland, France, Germany, Guatemala, India, Hungary, Iceland, Korea Republic of, Philippines, Spain, Poland, Romania, Singapore, Sweden, United Kingdom

NCT01555125

3

177

First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks

United States, Canada, Estonia, France, Germany

NCT01636687

3

182

Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)

United States, Canada, Estonia, France, Germany

NCT01406938

3

967

Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens

United States, Austria, Bulgaria, Canada, Czech Republic, France, Germany, India, Italy, Japan, Poland, Singapore, Slovakia, Vietnam, Switzerland, United Kingdom

NCT01412944

3

43

Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis

United States, Austria, Canada, Czech Republic, France, Germany, India, Japan, Slovakia

Phase 2 studies in psoriasis

NCT01412944

2

404

AIN457 Regimen Finding Study in Patients with Moderate to Severe Psoriasis

United States, France, Germany, Iceland, Israel, Japan, Norway

NCT00805480

2

130

Multiple-loading Dose Regimen Study in Patients with Chronic Plaque-type Psoriasis

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