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Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF)

Study Purpose

Orally administered ME-015 (Suplatast Tosilate) has been available on the market as a prescription drug for allergy-related conditions in Japan since 1995 with a very good safety and tolerability profile. There is preclinical and exploratory clinical evidence suggesting that ME-015 may be effective in treating cough caused by idiopathic pulmonary fibrosis (IPF-cough). 80% of patients with idiopathic pulmonary fibrosis (IPF) are affected by a devastating dry cough that is often not responsive to standard cough treatments and causes significant psychological and physiological suffering as well as reduced quality of life. As of July 2023, there is no approved treatment for the indication of IPF-cough. There is an enormous unmet clinical need for an effective, safe and well-tolerated oral treatment. The COSMIC-IPF Phase 2 trial is the first clinical trial assessing ME-015 for the treatment of IPF-cough and aims to generate clinical proof-of-concept results regarding the safety and efficacy of ME-015 in this condition.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of idiopathic pulmonary fibrosis (IPF) according to the 2018 American Thoracic Society (ATS) guidelines, confirmed by high-resolution computed tomography (HRCT) chest scan taken within < 2 years.
  • - Age ≥ 18 years.
  • - Cough attributed to IPF unresponsive to standard anti-tussive treatment and present for > 8 weeks.
  • - Arithmetic mean of ≥ 10 coughs/hour during waking hours.
  • - Ability to read, comprehend, and complete the informed consent form (ICF) and all questionnaires in the study without help.
  • - Cough severity score of ≥ 40 mm on a 0-to-100 mm Visual Analogue Scale (VAS) - Life expectancy > 6 months.
  • - Stable medical condition: stable treatment for > 12 weeks and absence of acute exacerbations for > 4 weeks.
  • - Antifibrotics pirfenidone and nintedanib are allowed if the patient has been on a stable dose for ≥ 12 weeks and remains on a stable dose throughout the study.
  • - Forced vital capacity (FVC) ≥ 40% predicted.
  • - Ratio between forced expiratory volume in one second and forced vital capacity (FEV1 / FVC) ≥ 65% - Women of childbearing potential must agree to use a highly effective method of contraception.
  • - Male partner must agree to use a condom during the study, unless they had a vasectomy > 6 months prior to first study drug administration.

Exclusion Criteria:

  • - Likely need for lung transplantation in next 12 months.
  • - Permanent long-term oxygen therapy.
  • - Use of high-dose corticosteroids or cytotoxic medications.
  • - History of unstable or deteriorating cardiac or pulmonary disease in the preceding 6 months.
  • - Current smoking, vaping, or tobacco chewing.
  • - Treatment with an angiotensin-converting enzyme (ACE) inhibitor or sitagliptin started in the last 12 weeks.
  • - Suspected acute infection, including COVID-19 or influenza or any upper respiratory tract infection.
  • - History of malignancy within the last 2 years.
  • - History of drug/alcohol dependency/abuse within the last 2 years.
  • - Recent history of stroke or transient ischemic attack.
  • - Blood pressure > 160/90 mmHg.
  • - Pregnant/lactating women.
  • - Exposure to an investigational drug or biologic within the last 2 months.
  • - Blood donation within the last 56 days or plasma donation within the last 7 days.
- Body Mass Index < 18 kg/m2 or ≥ 40 kg/m2

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05983471
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Melius Pharma AB
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries India
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis, Cough
Study Website: View Trial Website
Additional Details

This double-blind, cross-over, placebo-controlled clinical trial will randomize patients with stable idiopathic pulmonary fibrosis (IPF) and cough related to IPF (IPF-cough) in a 1:1 fashion to one of two treatment sequences: active treatment followed by placebo, or placebo followed by active treatment. Each 14-day active/placebo treatment phase is preceded by a wash-out period. The treatment sequences are followed by an observational 7-day follow-up period without medication. All subjects in the trial receive standard-of-care antifibrotic treatment for IPF. Treatment assignment is blinded to patients, investigators, site personnel, data analysts and Sponsor. The active treatment is ME-015 (Suplatast Tosilate) 200 mg t.i.d. (three times per day) administered as oral capsules. The placebo treatment consists of identical capsules without the active component. The primary efficacy endpoint is the effect on wake time cough frequency measured objectively with the VitaloJak device over a 24-hour period. VitaloJak recordings are analysed using a blinded, independent, central review process. The study is conducted as a single-country, multi-site clinical trial in India with Melius Pharma AB as the Sponsor.

Arms & Interventions

Arms

Experimental: ME-015 (Suplatast Tosilate)

ME-015 (Suplatast Tosilate) 2 x 100 mg capsule t.i.d. (three times per day), for 2 weeks

Placebo Comparator: Placebo

Identical placebo capsules 2 x t.i.d. (three times per day), for 2 weeks

Interventions

Drug: - ME-015 (Suplatast Tosilate)

Oral capsule form, 200 mg t.i.d. (total 600 mg per 24 hours)

Other: - Identical placebo

Without active component

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Aditya Multi Specialty Hospital, Guntur, Andhra Pradesh, India

Status

Address

Aditya Multi Specialty Hospital

Guntur, Andhra Pradesh,

Site Contact

Goli M Venkata Kasiram, MD

chris.nowak@meliuspharma.com

+46739806535

Hindusthan Hospital, Chennai, Tamil Nadu, India

Status

Address

Hindusthan Hospital

Chennai, Tamil Nadu,

Government Chest Hospital, Hyderabad, Telangana, India

Status

Address

Government Chest Hospital

Hyderabad, Telangana,

Site Contact

Karthik Velimala, MD

chris.nowak@meliuspharma.com

+46739806535

Health Point Hospital, Kolkata, West Bengal, India

Status

Address

Health Point Hospital

Kolkata, West Bengal,

Site Contact

Amitabha Sengupta, MD

chris.nowak@meliuspharma.com

+46739806535