A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)

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Brief Title

A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)

Official Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Takayasu Arteritis

Brief Summary

      The purpose of this study is to evaluate the efficacy of ustekinumab compared to placebo, in
      combination with oral glucocorticoid (GC) taper regimen, in participants with relapsing
      Takayasu Arteritis (TAK).
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Time to Relapse Through the End of Double-blind (DB) Period

Secondary Outcome

 Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Condition

Takayasu Arteritis

Intervention

Ustekinumab

Study Arms / Comparison Groups

 Ustekinumab
Description:  Double-blind (DB) Period: Participants will receive weight-ranged based ustekinumab (6 milligrams/kilogram[mg/kg]) as IV infusion at Week 0 followed by ustekinumab 90mg injection SC 8 weeks after initial IV dose, then every 8 weeks (q8w) thereafter until the end of the DB period with starting the protocol defined oral GC taper regimen from Week 2 visit.
Open Label Extension (OLE) period: Participants will receive ustekinumab SC injection at Week OL-0, followed by ustekinumab 90mg SC injection with oral GC taper at investigator's discretion for 52 weeks (Week OL-52) or until 32 weeks from first SC administration after end of DB period whichever is later.
Long-term Extension (LTE) Period: Participants who completed OLE period may be eligible to enter LTE and continue to receive ustekinumab 90mg SC injection q8w.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

September 6, 2021

Completion Date

June 11, 2025

Primary Completion Date

June 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Must have developed a relapse of Takayasu Arteritis (TAK) within 12 weeks prior to
             administration of study intervention and the relapse must have occurred at a dose of
             at least 7.5 milligrams (mg)/day (prednisolone or equivalent)

          -  Must be receiving oral glucorticoid (GC) treatment of greater than or equal to (>=)15
             mg/day (prednisolone or equivalent), inclusive for the treatment of relapsing TAK and
             be on a stable dose for at least 2 weeks prior to the first administration of study
             intervention

          -  If receiving an oral anti-platelet therapy (including but not limited to aspirin,
             clopidogrel, ticlopidine) or anti-coagulation therapy (including but not limited to
             warfarin) for treatment of TAK, the dose must have been stable for at least 2 weeks
             prior to first administration of the study intervention. In terms of warfarin, the
             dose should be controlled 1-5mg/day to maintain Prothrombin Time and International
             Normalized Ratio (PT-INR) target range between 2.0-3.0 (if participants are over 70
             years old, PT-INR target range should be between 1.6-2.6)

          -  Have no history of latent or active Tuberculosis (TB) prior to screening. An exception
             is made for participants who have a history of latent TB and are currently receiving
             treatment for latent TB, will initiate treatment for latent TB at least 3 weeks prior
             to the first administration of the study intervention, or have documentation of having
             completed appropriate treatment for latent TB within 3 years prior to the first
             administration of the study intervention. It is the responsibility of the investigator
             to verify the adequacy of previous antituberculous treatment and provide appropriate
             documentation

          -  If receiving an oral anti-hypertensive therapy for treatment of TAK, the dose must
             have been stable for at least 2 weeks prior to first administration of the study
             intervention

        Exclusion Criteria:

          -  Has currently any known severe or uncontrolled TAK complications (example,
             hypertension not responding to adequate treatment, aortic incompetence with cardiac
             insufficiency, progressing aortic aneurysm, coronary artery lesions with severe
             stenosis)

          -  Has received Methotrexate (MTX), Azathioprine (AZA), Mycophenolate Mofetil (MMF), oral
             Triamcinolone (TAC), oral Cyclosporine A within 4 weeks of first study intervention

          -  Has had a Bacille Calmette-guerin (BCG) vaccination within 12 months of screening

          -  Any major illness/condition or evidence of an unstable clinical condition example,
             history of liver or renal insufficiency (estimated creatinine clearance below 60
             milliliters/minute [mL/min]); significant (cardiac, vascular, pulmonary,
             gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or
             metabolic disturbances), disease of any organ system or active acute or chronic
             infection/infectious illness that, in the investigator's judgment, will substantially
             increase the risk to the participant if he or she participates in the study

          -  Having a condition that is steroid dependent (example, steroid dependent asthma,
             chronic obstructive pulmonary disease, et cetera) that is not amenable to tapering
             oral GC
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Janssen Pharmaceutical K.K., Japan Clinical Trial, 844-434-4210, [email protected]

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT04882072

Organization ID

CR108981

Secondary IDs

CNTO1275TAT3001

Responsible Party

Sponsor

Study Sponsor

Janssen Pharmaceutical K.K.


Study Sponsor

Janssen Pharmaceutical K.K., Japan Clinical Trial, Study Director, Janssen Pharmaceutical K.K.


Verification Date

September 2021