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An Open-Label Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SM04646 Inhalation Solution in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Study Purpose

SM04646-IPF-03 is a Phase 2a, multi-center, open-label study evaluating the safety and efficacy of a single inhaled, nebulized dose of SM04646 solution over a 12-week treatment regimen in subjects with mild to moderate IPF. A total of approximately 24 subjects will be enrolled in the study (approximately 12 subjects into the "non-bronchoalveolar lavage [BAL]" arm and approximately 12 subjects into the "BAL" arm). Subjects that currently do not require, have failed to tolerate, or have opted not to have treatment with pirfenidone or nintedanib will have the option of participation in the "BAL" arm or participation in the "non-BAL" arm. Subjects currently receiving treatment with pirfenidone or nintedanib must be on stable treatment for a minimum of 12 weeks prior to the Screening Visit. Subjects currently on treatment with pirfenidone or nintedanib may participate in the "non-BAL" arm only. Eligible subjects will participate in a treatment period of 12 weeks and a follow-up period of 12 weeks. The treatment dosing pattern will follow a 2 weeks on, 2 weeks off regimen, wherein subjects will dose 5 consecutive days of each 7 day "on" week.

Recruitment Criteria

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

Accepts Healthy Volunteers
No

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.

Study Type
Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - IPF diagnosis within 5 years of study start based upon thoracic society guidelines and confirmed by Investigator at study start - Able to walk > 150 m in 6 Minute Walk Test without the use of supplemental oxygen at study start - Has a life expectancy of at least 12 months in the opinion of the Investigator - Full understanding of the requirements of the study and willingness and ability to comply with all study visits and procedures - Able to comprehend and willing to sign an informed consent form (ICF) prior to any study-related procedure being performed - Able to tolerate and complete placebo (vehicle) inhalation for 10 minutes without experiencing a significant cough, in the opinion of the Investigator - Subjects currently treated with pirfenidone or nintedanib must be willing to remain on their current treatment for the duration of the protocol, unless they experience rapid progression, or if, in the opinion of the Investigator, treatment adjustments are necessary

    Exclusion Criteria:

    - Women who are pregnant or lactating - Women of childbearing potential who are sexually active and are not willing to use an appropriate method of birth control during the study treatment period until 90 days post study medication administration - Males who are sexually active and not willing to use a condom, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use an appropriate method of birth control during the study treatment period until 90 days post study medication administration - Males unwilling to refrain from sperm donation during the study treatment period until 90 days post study medication administration - Subjects unwilling to refrain from blood and plasma donation during the study treatment period until 90 days post study medication administration - A history of abuse of prescription or illicit drugs within 6 months prior to study start - Positive urine drug and alcohol screen with the exception of positive findings related to current prescription therapy at study start - Occurrence of serious illness requiring hospitalization within 90 days prior to study start - Presence of active infections at study start - Current smoker or past history of smoking (e.g., cigarettes, e-cigarettes, pipes, cigars) within 6 months of study start or >50 pack years - Use of non-inhaled tobacco- or nicotine-containing products (e.g., chewing tobacco, nicotine gum, lozenges, or patches) within 30 days prior to study start until completion of the study - Regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 30 days prior to study start until completion of the study - Lung transplantation anticipated during the duration of the trial - Subjects receiving treatment with pirfenidone or nintedanib that: 1.
Have been on treatment for less than 12 weeks prior to study start 2. Have not been on a stable dose for at least 30 days prior to study start
  • - Subjects who are not currently on but have previously received pirfenidone or nintedanib that have not been off of pirfenidone or nintedanib for at least 30 days prior to study start - Receipt of any of the following medication or treatment prior to study start: 1.
N-acetylcysteine prescribed for the treatment of IPF within 30 days prior to study start 2. Previous therapeutic radiation treatment of the lungs, mediastinum, or chest wall 3. Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 30 days or 5 half-lives of the investigational product (if known), whichever is longer, prior to study start 4. Immunosuppressive medications [e.g., methotrexate, cyclosporine, azathioprine, systemic or inhaled glucocorticosteroids with the exception of short term use of systemic glucocorticosteroids less than or equal to 10 mg of prednisone daily (or equivalent) for a non-IPF condition such as an allergic reaction or rash] within 8 weeks prior to study start 5. Use of any therapy targeted to treat IPF (including but not limited to d-penicillamine, endothelium receptor antagonist [e.g., bosentan, ambrisentan], and interferon gamma-1B) within 30 days prior to study start 6. Use of any cytokine modulator (etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab, rituximab) within 90 days or 5 half-lives, whichever is longer, prior to study start 7. A bronchodilator used within 1 week of study start 8. SM04646
  • - A "bronchodilator response" at study start, defined by an absolute increase of ≥ 12% and an increase of 0.2 L in FEV1 or FVC, or both, after bronchodilator use compared with the values before bronchodilator use - History of any of the following conditions: 1.
Pulmonary embolism or pulmonary hypertension 2. Creatinine clearance of less than 50mL per minute 3. Active tuberculosis (TB) infection or history of incompletely treated latent TB infection 4. History of malignancy within the last 5 years; however, the following subjects are eligible: 1. Subjects with prior history of in situ cancer or basal or squamous cell skin cancer that has been completely excised 2. Subjects with other malignancies if they have been continuously disease free for at least 5 years prior to any study drug administration 3. Subjects with prostate cancer followed by surveillance. 5. Any connective tissue disease, including but not limited to scleroderma, systemic lupus erythematosus, rheumatoid arthritis, and polymyositis/dermatomyositis 6. Congenital respiratory conditions (e.g., cystic fibrosis) 7. Chronic obstructive pulmonary disease (COPD) or asthma 8. Current or recent respiratory tract infection (e.g., pneumonia, purulent bronchitis, or viral upper respiratory tract infection) within 30 days prior to study start 9. Acute exacerbation of IPF, in the opinion of the Investigator, within 30 days prior to study start 10. Human immunodeficiency virus (HIV), hepatitis C, or active hepatitis B infection 11. Clinically significant hepatic impairment (e.g., Child-Pugh A or greater severity) 12. Symptomatic coronary artery disease, congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV, myocardial infarction (MI), or unstable angina within 6 months prior to study start 13. Hypertension (systolic blood pressure (SBP) >160 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) >100 mmHg) 14. Hypotension (blood pressure (BP) less than 90/60 mmHg) or mean arterial blood pressure (MAP) < 65 mmHg 15. Current use of supplemental oxygen therapy for any condition - Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site - Subjects employed by Samumed Pacific Pty Ltd, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study

Trial Details

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.

Trial ID:
NCT03591926

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
Phase 2

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

Lead Sponsor
Samumed LLC

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

Principal Investigator
Yusuf Yazici, M.D.
Principal Investigator Affiliation Samumed LLC

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

Agency Class
Industry
Overall Status Not yet recruiting
Countries Australia, New Zealand

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

Conditions
Idiopathic Pulmonary Fibrosis

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

Research Site, Dunedin, New Zealand

Status

Not yet recruiting

Address

Research Site

Dunedin, ,

Site Contact

1-855-222-0515

Research Site, Christchurch, New Zealand

Status

Not yet recruiting

Address

Research Site

Christchurch, ,

Site Contact

1-855-222-0515

Research Site, Clayton, Victoria, Australia

Status

Not yet recruiting

Address

Research Site

Clayton, Victoria,

Site Contact

1-855-222-0515

Research Site, Bedford Park, South Australia, Australia

Status

Not yet recruiting

Address

Research Site

Bedford Park, South Australia,

Site Contact

1-855-222-0515

Research Site, Concord, New South Wales, Australia

Status

Not yet recruiting

Address

Research Site

Concord, New South Wales,

Site Contact

1-855-222-0515

Research Site, Camperdown, New South Wales, Australia

Status

Not yet recruiting

Address

Research Site

Camperdown, New South Wales,

Site Contact

1-855-222-0515

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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