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EUCTR2016-003403-66

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

Data source: WHO (Imported from 18.10.2020)
Changed: 18.10.2020
Disease category:

Health conditions (Data source: WHO)

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]

Interventions (Data source: WHO)


Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Nintedanib
Current Sponsor code: BIBF 1120
Other descriptive name: NINTEDANIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Nintedanib
Current Sponsor code: BIBF 1120
Other descriptive name: NINTEDANIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria:
1. Patients who completed the SENSCIS/1199-0340 trial per protocol and did not permanently discontinue 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 or > 1
week between ast nintedanib in trial 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

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003403-66

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2016-003403-66-GB

Further information on trial

Date trial registered

09.01.2018

Incorporation of the first participant

07.02.2018

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

Main Objective: The main objective is to assess long term safety of treatment with oral nintedanib in patients
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

Secundary end point (Data source: WHO)

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

Contact information (Data source: WHO)

Boehringer Ingelheim

Trial results (Data source: WHO)

Results summary

An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD)

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States

Contact for further information on the trial

Contact for general information (Data source: WHO)

CT Disclosure & Data Transparency
Binger Strasse 173
Boehringer Ingelheim Pharma GmbH & Co. KG
+1800243 0127
clintriage.rdg@boehringer-ingelheim.com

Contact for scientific information (Data source: WHO)

CT Disclosure & Data Transparency
Binger Strasse 173
Boehringer Ingelheim Pharma GmbH & Co. KG
+1800243 0127
clintriage.rdg@boehringer-ingelheim.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Boehringer Ingelheim Limited

Further trial identification numbers

Secondary ID (Data source: WHO)

1199.225
2016-003403-66-NL