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

Novartis

Status and phase: Completed; Phase 3

Conditions: Plaque-type Psoriasis

Treatments: Drug: Secukinumab 150mg; Drug: Secukinumab 300mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01636687

CAIN457A2309

2012-002609-22 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.

• Severity of psoriasis disease meeting all of the following three criteria:

  • Psoriasis Area and Severity Index (PASI) score of 12 or greater
  • Investigator's Global Assessment (IGA) score of 3 or greater
  • Total body surface area (BSA) affected of 10% or greater

• Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

Exclusion criteria

• Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
• Current drug-induced psoriasis.
• Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
• Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
• Hematological abnormalities.
• History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
• History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
• Pregnant or nursing (lactating) women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

182 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects who were in placebo at Week 52 cannot continue in the extension treatment period

Treatment:

Drug: Placebo

Secukinumab 150 mg

Experimental group

Description:

After the data base lock of week 52 data has been performed, subjects received secukinumab 150 mg treatment as open label for the remainder of the extension treatment period.

Treatment:

Drug: Secukinumab 150mg

Secukinumab 300 mg

Experimental group

Description:

After the data base lock of week 52 data has been performed, subjects received secukinumab 300 mg treatment as open label for the remainder of the extension treatment period.

Treatment:

Drug: Secukinumab 300mg