Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis

Phase 3

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Placebo 2 mL auto-injector; Drug: Placebo 1 mL prefilled syringe; Drug: Secukinumab 2 mL auto-injector; Drug: Secukinumab 1 mL prefilled syringe

• Registration Number: NCT03589885
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis

Detailed Description

This is a 52-weeks multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis

Study Timeline

• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-05
• Study First Posted: 2018-07-18
• Study Start: 2018-12-19
• Primary Completion: 2019-11-19
• Disposition First Submitted: 2020-02-12
• Study Completion: 2020-08-05
• Results First Submitted: 2021-07-12
• Results First Submitted QC: 2021-08-05
• Disposition First Submitted QC: 2021-08-05
• Results First Posted: 2021-08-26
• Disposition First Posted: 2021-08-26
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Subjects eligible for inclusion in this study must have fulfilled all of the following criteria:

1. Men or Women of at least 18 years of age at time of Screening

2. Subjects able to understand and communicate with the investigator and comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed. Where relevant, a legal representative signed the informed study consent according to local laws and regulations.

3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Randomization.

4. Moderate to severe psoriasis as defined at Randomization by:

   • PASI score of 12 or greater, and
   • IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4), and
   • Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.

5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by

   • Topical treatment and/or
   • Phototherapy and/or
   • Previous systemic therapy

Read More

Exclusion Criteria

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Randomization.

2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol had to be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study were considered not eligible for this study since UV light exposure was prohibited.

   Note: administration of live vaccines 6 weeks prior to Randomization or during the study period was also prohibited.

3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.

4. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect had returned to baseline, whichever is longer; or longer if required by local regulations.

5. Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.

6. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there was evidence of local recurrence or metastases (except for Bowen's disease, or basal cell carcinoma or actinic keratoses that had been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).

7. History of hypersensitivity to any of study drug constituent

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo 2 mL auto-injector	Placebo 2 mL auto-injector	Placebo to secukinumab s.c., provided in 2 mL auto-injector form
Placebo 1 mL prefilled syringe	Placebo 1 mL prefilled syringe	Placebo to secukinumab s.c., provided in 2 \* 1 ml prefilled syringe form
Secukinumab 2 mL auto-injector	Secukinumab 2 mL auto-injector	Secukinumab 300 mg provided in 2 mL auto-injector form
Secukinumab 1 mL prefilled syringe	Secukinumab 1 mL prefilled syringe	Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL

Primary Outcome Measures

Name	Time	Method
PASI 75 Response After 12 Weeks of Treatment	12 weeks	Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline. A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).
IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment	12 weeks	Percentage of participants who achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline. This scale ranges from 0 (clear, no signs of psoriasis) to 4 (severe).

Secondary Outcome Measures

Name	Time	Method
PASI 90 Response	12 weeks	Percentage of participants who achieve ≥ 90% reduction in PASI compared to baseline
PASI 50, 75, 90 and 100 and IGA Mod 2011 0 or 1 Response	52 weeks	Percentage of participants who achieve ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline at each visit up to 52 weeks
Successful Self-injection	From randomization until Week 28	Subject usability (ability to follow instructions for use and potential use-related hazards) and satisfaction with the new secukinumab 2 mL AI utilizing a self-administered Self-Injection Assessment Questionnaire (SIAQ) and investigator/site staff observation of secukinumab 300 mg 2 mL AI administration. The Satisfaction with Self-Injection (SA) domain score ranges from 0 (worst experience) to 10 (best experience).
Dermatology Life Quality Index, (DLQI) 0 or 1 Score (Total Score)	Change from Baseline up to 52 weeks	DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇪🇸 Madrid, Spain