Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease (ATtackMy-ILD)

  • STATUS
    Recruiting
  • End date
    May 30, 2023
  • participants needed
    20
  • sponsor
    Rohit Aggarwal, MD
Updated on 13 May 2022
tacrolimus
cyclophosphamide
cyclosporine
methotrexate
immunosuppressive
rituximab
prednisone
anakinra
immunosuppressive agents
infliximab
tumor necrosis factor
etanercept
myositis
pulmonary disease
immunosuppressants
immunosuppression
azathioprine
leflunomide
abatacept
igiv
mycophenolate
intravenous immunoglobulin
tocilizumab
pirfenidone
interstitial lung disease
ciclosporin

Summary

A randomized, controlled pilot trial to evaluate the efficacy and safety of subcutaneous Abatacept in treating interstitial lung disease associated with the anti-synthetase syndrome.

Description

This is a proof of concept study to evaluate the efficacy, safety and tolerability of abatacept in Syn-ILD in a multi-center randomized, placebo-controlled 6-month (24-week) pilot study.

Details
Condition Myositis, Interstitial Lung Disease
Treatment Placebo, Abatacept
Clinical Study IdentifierNCT03215927
SponsorRohit Aggarwal, MD
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Anti-synthetase syndrome defined as the patient possessing 1 antisynthetase autoantibody (Jo-1, PL-12, PL-7, KS, OJ, EJ, Zo) in the presence of autoimmune ILD
ILD defined by radiographic (HRCT chest) findings of reticulation, honeycombing or ground glass opacities (GGO) without another plausible explanation. HRCT chest defining ILD for inclusion criteria, should be within last 1 year done as SOC
Active ILD (see Section 4.2)
Baseline FVC a) % <80% b) FVC 80-100% with > = 10% decline in FVC in last 12 months as minimal threshold of ILD severity (PFT done within last 3 months is acceptable for inclusion criteria determination)
SOC immunosuppressive therapy (IS) therapy
Steroids (prednisone or other forms of steroid in equivalent doses) OR one of the other immunosuppressive agent (either Mycophenolate (MMF) or Azathioprine (AZA) OR a combination of steroid and an immunosuppressive agent. MMF (maximum of 3 gm/day) or azathioprine (maximum of 200 mg/day).Goal is to start the trial drug (or placebo) soon after starting SOC (MMF/AZA/Steroids) and their doses are stable. Note that patients on steroids alone as well as not on steroids can be enrolled in the trial as well
Desired dose of the SOC therapy should be reached 4 weeks prior to first study visit (Visit 1). No dose changes are allowed 4 weeks prior to first study visit
Dose of concomitant therapy (SOC) cannot be changed during the 24 weeks of the trial unless safety/toxicity issues supervene
If on steroid, the steroid dose must be stable for 2 weeks prior to Visit 1
No other concomitant IS medications including methotrexate, cyclosporine, intravenous
No concomitant biologic agents (i.e. rituximab, anti-tumor necrosis factor (TNF) agents, tocilizumab)
immunoglobulin (IVIG), tacrolimus, cyclophosphamide or tofacitinib
Additional IS therapy: Patient cannot begin any new IS therapy or new steroid taper for the 24-week study period, except if severe clinical worsening (flare up) of the disease requiring rescue therapy occurs (i.e. documentation of worsening of PFT/HRCT and patient and physician determination of worsening). See section of rescue medication below for details
If the enrolling physician is planning to discontinue current IS agent or steroid before clinical trial, then following washout period is required prior to Visit 1
Medication Washout Period methotrexate 4 weeks Other IS agent (e.g
azathioprine, cyclosporine, tacrolimus, leflunomide, mycophenolate mofetil) 4
weeks IVIg or cyclophosphamide 3 months rituximab 6 months infliximab or
adalimumab 8 weeks glucocorticoids 2 weeks etanercept 2 weeks anakinra 1 week
pirfenidone 4 weeks
Men and women of reproductive potential must agree to use an acceptable method of birth control during the trial period
Subject has provided written informed consent

Exclusion Criteria

A patient will be excluded if any of the following Exclusion Criteria are met
Severe end stage lung disease
FVC ≤30% or Forced expiratory volume (FEV1) ≤ 30% or
Requirement of high O2 requirement ≥ 6 L/min at rest for >1 month before the study enrollment or
Listed for lung transplantation or
PI feels that ILD is severe and end stage fibrosis is such that there is low potential for improvement with any disease modifying intervention
Subjects under the age of 18
Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds)
Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening
Active tuberculosis (TB) requiring treatment within the previous 3 years. Patients should be screened for latent TB using purified protein derivative (PPD)/or quantiferon gold within last 1 year and, if positive, treated following local practice guidelines prior to initiating abatacept (ABT). Patients treated for active tuberculosis with no recurrence in 3 years are permitted
Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation
Pregnant women or nursing (breast feeding) mothers
History of alcohol, drug or chemical abuse within 1 year prior to screening or any medical condition or physical or psychological state that the PI feels would not allow the subject to safely complete the study
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
Treatment with any other investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
Previous treatment with the following cell-depleting therapies, including investigational agents or approved therapies: CAMPATH, anti-CD4, anti-CD5, and anti-CD3
Previous treatment with ABT
History of severe allergic or anaphylactic reactions to monoclonal antibodies
Evidence of serious uncontrolled concomitant cardiovascular, nervous system, renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn's disease.)
Evidence of concomitant lung disease which PI feels may interfere with clinical assessment of ILD for example severe active chronic obstructive pulmonary disease (COPD), asthma, occupational lung disease, pulmonary sarcoidosis, etc
Prisoners or subjects who are compulsory detained
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