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Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment (AgAIN)

Primary Purpose

Psoriatic Arthritis

Status
Recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Secukinumab
Ustekinumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, Psoriasis Arthropathica, Psoriatic Arthropathy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diagnosis of PsA as classified by CASPAR criteria for at least 6 months before randomization.
  • Active PsA at baseline defined as ≥ 3 tender joints out of 68 and ≥ 3 swollen joints out of 66 (dactylitis of a digit counts as one joint each).
  • Inadequate response or intolerance to previous or current treatment with at least one TNFα inhibitor
  • Inadequate response or intolerance to conventional disease modifying anti-rheumatic drugs (cDMARDs)
  • Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter and/or nail changes consistent with psoriasis and/or documented history of plaque psoriasis.
  • Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibodies negative at screening.

Key Exclusion Criteria:

  • Pregnant or nursing women,
  • Previous exposure to secukinumab, ustekinumab or any other biologic drug directly targeting IL-17, IL-17 receptor, IL-12 or IL-23.
  • Patients for whom the use of secukinumab or ustekinumab is contraindicated.
  • Use of any other investigational drug. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents
  • Evidence of ongoing infectious or malignant process
  • Subjects receiving high potency opioid analgesics
  • Ongoing use of prohibited psoriasis treatments/medications

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
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  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Secukinumab

Ustekinumab

Arm Description

AIN457

Outcomes

Primary Outcome Measures

Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
The disability assessment component of the HAQ assesses a subjects level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.

Secondary Outcome Measures

Proportion of patients achieving PASI 90
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 90 represents an improvement in the PASI score of at least 90% as compared with baseline.
Change from baseline in Patient's assessment of pain on VAS
Patient Reported Outcome: Patient's assessment of pain measures an individual's level of pain by marking a vertical tick on a horizontal VAS.
Change from baseline in Tender Joint Count (TJC) 68
TJC is determined by physical examination of 68 joint counts that are assessed for tenderness.
Change from baseline in Swollen Joint Count (SJC) 66
SJC is determined by physical examination of 66 joint counts that are classified as either swollen or not swollen.
Proportion of patients achieving PASI 100
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 100 represents an improvement in the PASI score of at least 100% as compared with baseline.
Proportion of patients achieving PASI 75
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 75 represents an improvement in the PASI score of at least 75% as compared with baseline.
Change from baseline in Patient's Global Assessment of Disease Activity on VAS
Patient Reported Outcome: Patient's global disease activity is recorded using a horizontal VAS.
Change from baseline in Patient's Global Assessment of Psoriasis and Arthritis Disease Activity on VAS
Patient Reported Outcome: Patient's Global Assessment of Psoriasis and Arthritis Disease Activity is recorded using a horizontal VAS.
Proportion of patients achieving Minimal Disease Activity (MDA)
MDA is achieved if 5 of 7 outcome measures are fulfilled: ≤ 1 TJC; ≤ 1 SJC; PASI ≤ 1 or BSA ≤3%, patient's assessment of pain on VAS ≤ 15; patient's global assessment of disease activity ≤ 20 (VAS);HAQ-DI ≤ 0.5; tender enthesial points ≤ 1.
Change from baseline in the Leeds Enthesitis Index (LEI)
The LEI was developed for the use in PsA and measures enthesitis at 6 sites.
Change from baseline in the Leeds Dactylitis Index (LDI)
The LDI measures the severity of dactylitis. The ratio of the circumfence of each affected digit to the circumfence of the digit on the opposite hand or foot is measured.
Change from baseline in Psoriatic Arthritis Quality of Life (PsAQoL)
Patient Reported Outcome: PsAQoL is a patient-administered 20-item questionnaire to evaluate the effect of PsA on a patient's quality of life.
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Patient Reported Outcome: FACIT-Fatigue is a questionnaire that measures an individual's level of fatigue and its impact upon daily activities and function.
Change from baseline in Dermatology Life Quality Index (DLQI) 0/1
Patient Reported Outcome: DLQI is a patient-administered and validated quality-of-life questionnaire that covers 6 domains.
Assessment of safety and tolerability of secukinumab 300 mg s.c. compared to ustekinumab
The incidence of clinically significant abnormal laboratory values/test results and adverse, serious adverse events (by review of values outside clinically notable ranges, significant changes from Baseline or the previous visit, or values, which are considered to be non-typical in participants with underlying disease)

Full Information

First Posted
November 4, 2020
Last Updated
September 13, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04632927
Brief Title
Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment
Acronym
AgAIN
Official Title
A 28-week, Randomized, Double-blind, Active Controlled, Multicenter Study to Evaluate the Efficacy of Subcutaneously Administered Secukinumab Compared to Ustekinumab in Adult Patients With Psoriatic Arthritis and Failure of TNFα- Inhibitor Treatment (AgAIN)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
October 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the safety and efficacy of secukinumab and ustekinumab in patients with active psoriatic arthritis who showed failure to previous TNFα-inhibitor treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriatic Arthritis, Psoriasis Arthropathica, Psoriatic Arthropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Secukinumab
Arm Type
Experimental
Arm Description
AIN457
Arm Title
Ustekinumab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Secukinumab
Other Intervention Name(s)
AIN457
Intervention Description
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Intervention Type
Biological
Intervention Name(s)
Ustekinumab
Intervention Description
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Primary Outcome Measure Information:
Title
Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description
The disability assessment component of the HAQ assesses a subjects level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.
Time Frame
28 Weeks
Secondary Outcome Measure Information:
Title
Proportion of patients achieving PASI 90
Description
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 90 represents an improvement in the PASI score of at least 90% as compared with baseline.
Time Frame
28 Weeks
Title
Change from baseline in Patient's assessment of pain on VAS
Description
Patient Reported Outcome: Patient's assessment of pain measures an individual's level of pain by marking a vertical tick on a horizontal VAS.
Time Frame
28 Weeks
Title
Change from baseline in Tender Joint Count (TJC) 68
Description
TJC is determined by physical examination of 68 joint counts that are assessed for tenderness.
Time Frame
28 Weeks
Title
Change from baseline in Swollen Joint Count (SJC) 66
Description
SJC is determined by physical examination of 66 joint counts that are classified as either swollen or not swollen.
Time Frame
28 Weeks
Title
Proportion of patients achieving PASI 100
Description
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 100 represents an improvement in the PASI score of at least 100% as compared with baseline.
Time Frame
28 Weeks
Title
Proportion of patients achieving PASI 75
Description
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI 75 represents an improvement in the PASI score of at least 75% as compared with baseline.
Time Frame
28 Weeks
Title
Change from baseline in Patient's Global Assessment of Disease Activity on VAS
Description
Patient Reported Outcome: Patient's global disease activity is recorded using a horizontal VAS.
Time Frame
28 Weeks
Title
Change from baseline in Patient's Global Assessment of Psoriasis and Arthritis Disease Activity on VAS
Description
Patient Reported Outcome: Patient's Global Assessment of Psoriasis and Arthritis Disease Activity is recorded using a horizontal VAS.
Time Frame
28 Weeks
Title
Proportion of patients achieving Minimal Disease Activity (MDA)
Description
MDA is achieved if 5 of 7 outcome measures are fulfilled: ≤ 1 TJC; ≤ 1 SJC; PASI ≤ 1 or BSA ≤3%, patient's assessment of pain on VAS ≤ 15; patient's global assessment of disease activity ≤ 20 (VAS);HAQ-DI ≤ 0.5; tender enthesial points ≤ 1.
Time Frame
28 Weeks
Title
Change from baseline in the Leeds Enthesitis Index (LEI)
Description
The LEI was developed for the use in PsA and measures enthesitis at 6 sites.
Time Frame
28 Weeks
Title
Change from baseline in the Leeds Dactylitis Index (LDI)
Description
The LDI measures the severity of dactylitis. The ratio of the circumfence of each affected digit to the circumfence of the digit on the opposite hand or foot is measured.
Time Frame
28 Weeks
Title
Change from baseline in Psoriatic Arthritis Quality of Life (PsAQoL)
Description
Patient Reported Outcome: PsAQoL is a patient-administered 20-item questionnaire to evaluate the effect of PsA on a patient's quality of life.
Time Frame
28 Weeks
Title
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Description
Patient Reported Outcome: FACIT-Fatigue is a questionnaire that measures an individual's level of fatigue and its impact upon daily activities and function.
Time Frame
28 Weeks
Title
Change from baseline in Dermatology Life Quality Index (DLQI) 0/1
Description
Patient Reported Outcome: DLQI is a patient-administered and validated quality-of-life questionnaire that covers 6 domains.
Time Frame
28 Weeks
Title
Assessment of safety and tolerability of secukinumab 300 mg s.c. compared to ustekinumab
Description
The incidence of clinically significant abnormal laboratory values/test results and adverse, serious adverse events (by review of values outside clinically notable ranges, significant changes from Baseline or the previous visit, or values, which are considered to be non-typical in participants with underlying disease)
Time Frame
28 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of PsA as classified by CASPAR criteria for at least 6 months before randomization. Active PsA at baseline defined as ≥ 3 tender joints out of 68 and ≥ 3 swollen joints out of 66 (dactylitis of a digit counts as one joint each). Inadequate response or intolerance to previous or current treatment with at least one TNFα inhibitor Inadequate response or intolerance to conventional disease modifying anti-rheumatic drugs (cDMARDs) Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter and/or nail changes consistent with psoriasis and/or documented history of plaque psoriasis. Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibodies negative at screening. Key Exclusion Criteria: Pregnant or nursing women, Previous exposure to secukinumab, ustekinumab or any other biologic drug directly targeting IL-17, IL-17 receptor, IL-12 or IL-23. Patients for whom the use of secukinumab or ustekinumab is contraindicated. Use of any other investigational drug. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents Evidence of ongoing infectious or malignant process Subjects receiving high potency opioid analgesics Ongoing use of prohibited psoriasis treatments/medications Other protocol-defined inclusion/exclusion criteria may apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Frankfurt
State/Province
Hesse
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bad Doberan
State/Province
Mecklenburg Vorpommern
ZIP/Postal Code
18209
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rendsburg
State/Province
Schleswig Holstein
ZIP/Postal Code
24768
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bad Bramstedt
ZIP/Postal Code
24576
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bad Pyrmont
ZIP/Postal Code
31812
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12435
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chemnitz
ZIP/Postal Code
09130
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Cottbus
ZIP/Postal Code
03042
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ehringshausen
ZIP/Postal Code
35630
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91056
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gommern
ZIP/Postal Code
39245
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Herne
ZIP/Postal Code
44649
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
51149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39110
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81541
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Planegg
ZIP/Postal Code
82152
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Potsdam
ZIP/Postal Code
14469
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Puettlingen/saar
ZIP/Postal Code
66346
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Ratingen
ZIP/Postal Code
40878
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment

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