Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis

AOP Orphan Pharmaceuticals AG160 enrolled

Overview

This is a dose-finding study for the investigational product Lancovutide (Moli1901) in the exploratory phase IIb to establish minimum effective dose, optimal dose, and maximum safe dose. Additionally, the tolerability of Moli1901 shall be investigated.

Study Moli1901-010B is a multi center, parallel group, placebo controlled, double-blind efficacy and safety evaluation of three different dosage schedules of aerosolized Moli1901 in adolescents (12 years of age or older), and adults. Study will start with a screening period (visit 1) followed by an 8 weeks double blind comparative treatment period (visit 2-7). Thereafter, subjects will be observed for additional 4 weeks without treatment (follow-up period and visit 8). Spirometry, pulse oximetry and other safety measurements will be performed up to 120 min after study medication inhalation. The study will be conducted in 30 sites in 9 European countries.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

Cystic Fibrosis

Interventions

Moli1901DRUG

2,5 ml inhalation solution, 8 weeks treatment period

Moli1901 placeboDRUG

2,5 ml placebo solution, 8 weeks treatment period

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index * Confirmed diagnosis of cystic fibrosis * FEV1 between 50% and 85% of predicted * Oxygen saturation level measured by pulse oximetry (SpO2) \>90 % on room air Exclusion Criteria: * Bronchial hyperresponsiveness * Unstable lung function * Pulmonary disease such as pneumonia, tuberculosis, or lung cancer * Acute upper respiratory tract infection within the last 2 weeks * Acute lower respiratory tract infection (requiring antibiotics or hospitalization) within the last 4 weeks * Pulmonary exacerbation within the last 4 weeks * Changes from routine maintenance therapy within the last 4 weeks * Scheduled changes to inhaled antibiotics regimen during the course of the study * Receive or are planned to receive any treatment via "on-off" regimen (e.g. Tobramycin - TOBI®); last dose of any "on-off" treatment within the last 6 weeks * Any clinically significant liver, renal, cardiac, neurological, or hematological disease * ABPA or colonization with Burkholderia cepacia * Poorly controlled diabetes mellitus

Locations (1)

Medical University

Graz, Austria

Outcomes

Primary Outcomes

The change in the percentage of the predicted FEV1 (forced expiratory volume in first second) value

Time frame: at every study visit

Secondary Outcomes

The ensemble of two subject reported clinical scores, which are physical dimensions of the self-report, disease-specific quality of life test, the cystic fibrosis questionnaire in the revised version

Time frame: every 2 weeks

Data from ClinicalTrials.gov

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