Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A

NCT02547714 | Completed Phase 4 Results

• 1 other identifier: CAIN457AJP01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study was to assess the efficacy and safety of secukinumab at Week 16 based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response to cyclosporine A.

Conditions

Plaque Psoriasis

Keywords

cyclosporine A

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75)

  PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 75 was defined as participants achieving \>= 75% improvement from baseline.

  Week 16

Secondary Outcomes (5)

• Mean Percent Change From Baseline in PASI Score

  Week 4

• Percentage of Participants Achieving PASI 50 or PASI 75

  Week 4

• Percentage of Participants Achieving PASI 90 and Investigator's Global Assessment (IGA) of 0 or 1 Response

  Week 16

• Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score

  Week 16

• Percentage of Participants Achieving DLQI 0 or 1

  Week 16

Study Arms (1)

Secukinumab (AIN457) 300 mg

EXPERIMENTAL

Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.

Drug: Secukinumab (AIN457)

Interventions

Secukinumab (AIN457) DRUG

Secukinumab was supplied as 150 mg doses, provided in 1 mL prefilled syringes.

Secukinumab (AIN457) 300 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Plaque psoriasis diagnosed for at least 6 months before baseline - Treated with cyclosporine A for at least 12 weeks prior to baseline
• Currently treated with cyclosporine A at baseline for psoriasis but is a primary or secondary inadequate response as defined at baseline by:
• PASI score of 10 or greater and
• IGA mod 2011 score of 2 or greater (based on a scale of 0 to 4)

You may not qualify if:

• Forms of psoriasis other than plaque (e.g., pustular, erythrodermic and guttate psoriasis). -Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium).
• Patients who have to discontinue cyclosporine A treatment due to side effects like renal impairment (serum creatinine exceeding 176.8 μmol/L \[2.0 mg/dL\]) and hypertension at screening.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (11)

Novartis Investigative Site

Nagoya, Aichi-ken, 467-8602, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 814-0180, Japan

Location

Novartis Investigative Site

Isehara, Kanagawa, 259-1193, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 550-0012, Japan

Location

Novartis Investigative Site

Shimotsuke, Tochigi, 329-0498, Japan

Location

Novartis Investigative Site

Chiyoda-ku, Tokyo, 102-8798, Japan

Location

Novartis Investigative Site

Itabashi-ku, Tokyo, 173-8606, Japan

Location

Novartis Investigative Site

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 105-8471, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 141 8625, Japan

Location

Novartis Investigative Site

Shinjuku-Ku, Tokyo, 169-0073, Japan

Location

MeSH Terms

Interventions

secukinumab

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: September 11, 2015
• Study Start: June 16, 2015
• Primary Completion: May 2, 2016
• Study Completion: May 2, 2016
• Last Updated: September 11, 2017
• Results First Posted: June 27, 2017

Record last verified: 2017-08

Locations

JP (11)