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

Psoriatic Arthritis Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04632927
• Other study ID #: CAIN457FDE04
• Secondary ID: 2019-004246-15
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 21, 2020
• Est. completion date: October 15, 2024

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 119
• Est. completion date: October 15, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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 TNFa 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Biological:
• Secukinumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
• Ustekinumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Bad Bentheim
Germany	Novartis Investigative Site	Bad Doberan	Mecklenburg Vorpommern
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Cottbus
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Ehringshausen
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Frankfurt	Hesse
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Gommern
Germany	Novartis Investigative Site	Gottingen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Herne
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Planegg
Germany	Novartis Investigative Site	Ratingen
Germany	Novartis Investigative Site	Rendsburg	Schleswig Holstein

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 Weeks
Secondary	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.	28 Weeks
Secondary	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.	28 Weeks
Secondary	Change from baseline in Tender Joint Count (TJC) 68	TJC is determined by physical examination of 68 joint counts that are assessed for tenderness.	28 Weeks
Secondary	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.	28 Weeks
Secondary	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.	28 Weeks
Secondary	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.	28 Weeks
Secondary	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.	28 Weeks
Secondary	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.	28 Weeks
Secondary	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.	28 Weeks
Secondary	Change from baseline in the Leeds Enthesitis Index (LEI)	The LEI was developed for the use in PsA and measures enthesitis at 6 sites.	28 Weeks
Secondary	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.	28 Weeks
Secondary	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.	28 Weeks
Secondary	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.	28 Weeks
Secondary	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.	28 Weeks
Secondary	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)	28 Weeks