A Study to Evaluate the Long-Term Safety of Nintedanib in Patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Overview

About this study

The purpose of this study is to assess the long-term tolerability and safety of oral nintedanib treatment in patients with Progressive Fibrosing Interstitial Lung Disease who have completed (and did not prematurely discontinue trial medication in) the phase III parent trial, 1199.247 (INBUILD®).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • Women of childbearing potential (WOCBP)* must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information
    • *A woman is considered of childbearing potential (WOCBP); i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation.  A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

Exclusion Criteria:

  • Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator's benefit-risk assessment remains favourable.
  • Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
  • Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.
  • Previous enrolment in this trial.
  • Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Teng Moua, M.D.

Closed for enrollment

Contact information:

Shannon Daley C.C.R.C., CCRP

(507) 293-0637

Daley.Shannon@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20506041

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