Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)

• Register: EUCTR
• Last refreshed on: 16 November 2020
• Main ID: EUCTR2018-004447-23-IT
• Date of registration: 10/11/2020
• Prospective Registration: No
• Primary sponsor: Respivant Sciences, GmbH
• Public title: Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)
• Scientific title: Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - SCENIC Trial
• Date of first enrolment: 18/06/2019
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004447-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Placebo-Controlled If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, Czech Republic, Czechia, Germany, Italy, Netherlands, New Zealand, Turkey, United Kingdom, United States

Contacts

• Name: Ahmet Tutuncu
• Affiliation: Respivant Sciences, Inc.

• Name: Ahmet Tutuncu
• Affiliation: Respivant Sciences, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female subjects age 40 through 89 years, inclusive
2. Confirmed diagnosis of IPF with clinical features consistent with the current clinical practice guidelines for IPF
3. Presence of persistent cough for at least 8 weeks that is primarily due to IPF and not responsive to antitussive therapy
4. Daytime cough severity score of =40 mm on a 100-mm VAS at the Screening Visit
5. 24-hour average cough count of at least 10 coughs per hour using an objective cough-count monitor during Screening
6. Forced Vital Capacity (FVC) > 45% predicted value within 4 weeks of the Screening Visit
7. Life expectancy of at least 12 months
8. Willing and able to follow the study required visits and assessments
9. Willing and able to use the cough monitor for 24-hour periods at select study visits
10. Willing and able to provide written informed consent prior to studyrelated procedures
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion criteria:
1. Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could place the subject at risk or compromise the quality of the study data as determined by the investigator
2. Significant coronary artery disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month of the Screening Visit)
3. An upper or lower respiratory tract infection within 4 weeks of the Screening Visit
4. Acute exacerbation of IPF within 6 months of the Screening Visit (Collard et al., 2016)
5. Lung transplantation expected within 12 months
6. Requiring supplemental O2 > 4 litres/min to maintain peripherial arterial O2 saturation (SpO2) > 88% at rest
7. History of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 2 years. This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma, prostate carcinoma or cervical carcinoma in situ)
8. Current smoker (i.e., use of tobacco products within the last 3 months)
9. Current or recent history of drug or alcohol abuse within 12 months of the Screning Visit
10. Participation in any other investigational drug study within 4 weeks of the Screening Visit or within 5 times the elimination half life of an investigational drug
11. Use of the following drugs for cough management within 4 weeks of the Screening Visit: prednisone, opiates, baclofen, gabapentin, pregabalin, thalidomide, amitriptyline, inhaled corticosteroids, or inhaled bronchodilators
12. Use of ACE inhibitors or cromolyn sodium within 4 weeks of the Screening Visit
13. Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control during the study (e.g., abstinence, combination barrier and spermicide, hormonal, or male partner sterilization)
14. History of hypersensitivity or intolerance to cromolyn sodium


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Persistent cough in Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1 Level: LLT Classification code 10070801 Term: Persistent cough System Organ Class: 100000004855

Intervention(s)

Product Name: cromolyn sodio (cromoglicato disodico, DSCG)
Product Code: [RVT-1601 (in precedenza PA101B)]
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: cromoglicato disodico
CAS Number: 15826-37-6
Current Sponsor code: RVT-1601 (in precedenza PA101B)
Other descriptive name: SODIUM CROMOGLICATE
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 7500-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use

Product Name: cromolyn sodio (cromoglicato disodico, DSCG)
Product Code: [RVT-1601 (in precedenza PA101B)]
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: cromoglicato disodico
CAS Number: 15826-37-6
Current Sponsor code: RVT-1601 (in precedenza PA101B)
Other descriptive name: SODIUM CROMOGLICATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use

Product Name: cromolyn sodio (cromoglicato disodico, DSCG)
Product Code: [RVT-1601 (in precedenza PA101B)]
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: cromoglicato disodico
CAS Number: 15826-37-6
Current Sponsor code: RVT-1601 (in precedenza PA101B)
Other descriptive name: SODIUM CROMOGLICATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: not less then
Concentration number: 60-
Pharmaceutical form of the placebo: Nebuliser solution
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Main Objective: To assess the efficacy of inhaled RVT-1601 in comparison with placebo following 12 weeks of treatment

Timepoint(s) of evaluation of this end point: Week 12.

Secondary Objective: • To select the optimal dose of RVT-1601
• To assess the pharmacokinetic (PK) profile of RVT-1601
• To assess biomarker response to RVT-1601
• To assess the impact of RVT-1601 on IPF disease
• To assess the safety of RVT-1601

Primary end point(s): Efficacy:
Primary endpoint:
• Change from baseline at the end of treatment in 24-hour average cough count

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 12.

Secondary end point(s): • Change from baseline at the end of treatment in cough severity as measured by VAS
• Change from baseline at the end of treatment in cough-specific QoL as measured by LCQ
• Proportion of responders with a minimum of 20% decrease from baseline at the end of treatment in 24-hour average cough count
• Change from baseline at the end of treatment in daytime average cough count
• Change from baseline at the end of treatment in nighttime average cough count
• Change from baseline at the end of treatment in ILD-specific QoL as measured by K-BILD
• Change from baseline at the end of treatment in respiratory-related QoL as measured by SGRQ
• Change from baseline at the end of treatment in dyspnea score as measured by SOBQ
• Change from baseline at the end of treatment in 6MWT
• Change from baseline at the end of treatment in FVC
• Proportion of subjects with no decline (i.e., < 5% decline), 5% - 10% decline, and > 10% decline in FVC % predicted at the end of treatment
• Change from baseline at the end of treatment in airway and lung volumes as measured by FRI
• Change from baseline at the end of treatment in average daily oxygen use
• Change from baseline at the end of treatment in exploratory biomarkers

Secondary ID(s)

2018-004447-23-NL

RVT1601-CC-04

Source(s) of Monetary Support

Respivant Sciences GmbH

Ethics review

Status: Approved
Approval date: 21/03/2019
Contact: