Safety and Tolerability of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis

NCT01169844 | Completed Phase 2 Results

• 1 other identifier: CAIN457A2206E1
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 6

Brief Summary

This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in psoriatic arthritis a decision will be made as to whether or not to continue dosing for another 6 month period (Part 2).

Conditions

Psoriatic Arthritis

Keywords

Psoriatic arthritis; IgG1K monoclonal antibody; Interleukin -17A neutralizing

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events and Serious Adverse Events

  Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.

  Up to 64 weeks (End of the Study Treatment)

Secondary Outcomes (2)

• Total IL-17 Concentration in Blood at Steady-state

  Up to 64 weeks

• Mean Serum Concentration Measured at Steady State

  Weeks 0, 8, 16, 20, 24, 28, 32, 36, 40 and at 4 and 12 weeks after the last administration at Week 52.

Study Arms (2)

AIN457/AIN457 3 mg/kg.

EXPERIMENTAL

Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.

Biological: AIN457A

Placebo/AIN457 3 mg/kg.

PLACEBO COMPARATOR

Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.

Biological: AIN457A; Other: Other

Interventions

AIN457A BIOLOGICAL

AIN457/AIN457 3 mg/kg.; Placebo/AIN457 3 mg/kg.

Other OTHER

Placebo/AIN457 3 mg/kg.

Eligibility Criteria

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

You may qualify if:

• Patients who participated and completed the core CAIN457A2206 study up to and including the end of the study (EoS) Visit, i.e. Visit 16 (Week 24), were allowed to enter the extension study upon signing informed consent.
• Patients who discontinued the core study due to unsatisfactory therapeutic effect at their Visit 14 (Week 16) or a later visit could enter the extension study within three weeks of completing the study discontinuation visit of the core study, provided that at their discontinuation visit they met the criteria below. Patients who did not enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, were to have an additional baseline visit (Visit 17) and required to meet the criteria below:
• The number of tender joints was the same or more than the core study baseline; or,
• The number of swollen joints was the same or more than the core study baseline; or,
• There was no improvement compared with the core study baseline in at least three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, Health Assessment Questionnaire and CRP

You may not qualify if:

• Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
• Patients who were non-compliant or who demonstrated a major protocol deviation in the core CAIN457A2206 study.
• Patients who discontinued from the core CAIN457A2206 study before Visit 14 (Week 16), and patients who completed the core study or discontinued the core study more than 2 weeks before the baseline visit.
• Pregnant or lactating women
• Presence of active infection
• Positive PPD or HIV test in patients where repeated testing was deemed appropriate due to their risk profile

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Hamburg, 22415, Germany

Location

Novartis Investigative Site

Amsterdam, DE, 1100, Netherlands

Location

Novartis Investigative Site

Meerssen, KR, 6231, Netherlands

Location

Novartis Investigative Site

Glasgow, G12 8TA, United Kingdom

Location

Novartis Investigative Site

Leeds, LS7 4SA, United Kingdom

Location

Novartis Investigative Site

Newcastle upon Tyne, NE2 4HH, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

+1 (862) 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 26, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 10, 2021
• Results First Posted: May 27, 2021

Record last verified: 2021-05

Locations

NL (2); DE (1); GB (3)