Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

PsoriasisModerate to Severe Plaque-type PsoriasisSkin conditionskin diseaseitching conditionpsoriasis vulgarisrelapsing/remitting psoriasisimmune-mediated systemic diseaseskin lesionsred skin lesionsscaly patchespapulesplaquesitching

Outcome Measures

Primary Outcomes (1)

Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response
Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis. PASI score was based on assessment of the head, trunk, upper limbs and lower limbs for erythema, thickening (plaque elevation, induration), and scaling (desquamation). PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretical maximum of 72.0. PASI-based secondary variables included absolute PASI score, response rates for PASI 75. PASI 50 and PASI 90 were defined as ≥ 50% and ≥ 90% improvement from Baseline in PASI score, respectively, while PASI 100 response corresponded to complete clearing of psoriasis (PASI = 0). IGA mod 2011 was used to evaluate the overall severity of psoriatic disease, with scores ranging from 0 (clear) to 4 (severe). Treatment success was defined as achievement of IGA mod 2011 0 or 1 score.
12 weeks

Secondary Outcomes (20)

Percentages of Subjects With Successful Self-administration of Study Drug at Week 1
Week 1

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Secukinumab 150 mg

EXPERIMENTAL

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.

Drug: Secukinumab 150mg

Secukinumab 300 mg

EXPERIMENTAL

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.

Interventions

PlaceboDrug

2 injections of placebo to secukinumab 150mg per dose

Placebo

Secukinumab 150mgDrug

Secukinumab 150mg: 1 injection of 150 mg secukinumab and 1 injection of placebo to secukinumab 150mg per dose. After Week 52 database lock, study is open label so only 1 injection of secukinumab 150mg per dose were administered

Secukinumab 150 mg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
Severity of psoriasis disease meeting all of the following three criteria:

Sponsors & Collaborators

Novartis Pharmaceuticals
Industrylead

Study Sites (39)

Novartis Investigative Site

Phoenix, Arizona, 85032, United States

Novartis Investigative Site

Los Angeles, California, 90045, United States

Novartis Investigative Site

Oceanside, California, 92056, United States

Novartis Investigative Site

Overland Park, Kansas, 66215, United States

Novartis Investigative Site

Louisville, Kentucky, 40202, United States

Novartis Investigative Site

Louisville, Kentucky, 40291, United States

Novartis Investigative Site

Omaha, Nebraska, 68144, United States

Related Publications (6)

Sticherling M, Nikkels AF, Hamza AM, Kwong P, Szepietowski JC, El Sayed M, Ghislain PD, Khotko AA, Patekar M, Ortmann CE, Forrer P, Papanastasiou P, Keefe D. Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials. Am J Clin Dermatol. 2023 Sep;24(5):821-835. doi: 10.1007/s40257-023-00782-8. Epub 2023 Jun 21.
PMID: 37341961DERIVED
Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.
PMID: 35305260DERIVED

MeSH Terms

Conditions

PsoriasisSkin DiseasesRecurrencePlaque, AmyloidPruritus

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalSkin ManifestationsSigns and Symptoms

Limitations and Caveats

Efficacy results after Wk 160 can't be interpreted meaningfully due to low # of evaluable patients. As per protocol, availability of AIN457 in participating countries led to discontinuation of most patients before they reached the later visits.

Results Point of Contact

Title: Study Director
Organization: Novartis Pharmaceuticals

Study Officials

Novartis Pharmaceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR

Publication Agreements

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

Enrollment

182 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 10, 2012

Study Start

October 17, 2012

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Study Arms (3)

Placebo

Secukinumab 150 mg

Secukinumab 300 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (39)

Related Publications (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Study Arms (3)

Placebo

Secukinumab 150 mg

Secukinumab 300 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (39)

Related Publications (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations