A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.

Phase 1

• Conditions: Systemic Sclerosis associated Interstitial Lung Disease; MedDRA version: 21.0Level: LLTClassification code 10012977Term: Diffuse systemic sclerosisSystem Organ Class: 100000004859; MedDRA version: 21.0Level: LLTClassification code 10036814Term: Progressive systemic sclerosisSystem Organ Class: 100000004859; MedDRA version: 20.0Level: PTClassification code 10042954Term: Systemic sclerosis pulmonarySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 21.0Level: LLTClassification code 10025109Term: Lung involvement in systemic sclerosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 21.0Level: LLTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-003403-66-GR
• Lead Sponsor: Boehringer Ingelheim B.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-14
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Patients who completed the SENSCIS/1199-0340 trial per protocol and did not permanently discontinue the study treatment
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
3. Women of childbearing potential1 must be ready and able 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. AST, ALT > 3 x ULN
2. Bilirubin > 2 x ULN
3. Creatinine clearance <30 mL/min
4. Clinically relevant anaemia at investigators discretion.
5. Bleeding risk, any of the following
a. Known genetic predisposition to bleeding according to the judgement of the
investigator
b. Patients who require
i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K
antagonists, direct thrombin inhibitors, heparin, hirudin)
ii. High dose antiplatelet therapy.
[Note: Prophylactic low dose heparin or heparin flush as needed for
maintenance of an indwelling intravenous device (e.g. enoxaparin 4000
I.U. s. c. per day), as well as prophylactic use of antiplatelet therapy (e.g.
acetyl salicylic acid up to 325 mg/day, or clopidogrel at 75 mg/day, or
equivalent doses of other antiplatelet therapy) are not prohibited].
c. Hemorrhagic central nervous system (CNS) event after completion of the
parent trial SENSCIS/1199-0340
d. Any of the following after last treatment of SENSCIS/1199-0340:
i. Haemoptysis or haematuria
ii. Active gastro-intestinal bleeding or GI – ulcers
iii. Gastric antral vascular ectasia (GAVE)
iv. Major injury or surgery (investigators judgement).
e. Coagulation parameters: International normalised ratio (INR) >2, prolongation
of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x
ULN at Visit 1.
6. New major thrombo-embolic events developed after completion of the parent trial
SENSCIS/1199-0340 :
a. Stroke;
b. Deep vein thrombosis;
c. Pulmonary embolism;
d. Myocardial infarction.
7. Major surgery (major according to the investigator’s assessment) performed within the
next 3 months
8. Time period > 12 weeks between last drug intake in SENSCIS/1199-0340 and Visit 2 of this trial.
9. Usage of any investigational drug after completion of the parent trial SENSCIS/1199-0340 or
planned usage of an investigational drug during the course of this trial.
10. A disease or condition which in the opinion of investigator may put the patient at risk
because of participation in this trial (e.g. clinically relevant intestinal pseudoobstruction)
or limit the patient’s ability to participate in this trial
11. Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes
them an unreliable trial subject or unlikely to complete the trial
12. Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
13. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
14. Previous enrolment in this trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to assess long term safety of treatment with oral nintedanib in patients<br>with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).;Secondary Objective: Not applicable;Primary end point(s): 1) The primary endpoint is the incidence of overall adverse events over the course of this extension trial.;Timepoint(s) of evaluation of this end point: 1) up to 34 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) n/a;Timepoint(s) of evaluation of this end point: 1) n/a