AzTrials
AzTrials

Idiopathic Pulmonary FibrosisPhase 2NCT05373914

RESPIRARE - Efficacy and Safety of Cudetaxestat in Patients With Idiopathic Pulmonary Fibrosis (IPF)

A Phase 2 study testing Cudetaxestat (BLD-0409) in people with Idiopathic Pulmonary Fibrosis, run by Blade Therapeutics.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The overall objective of this study is to evaluate the effectiveness and safety of cudetaxestat (BLD-0409) as compared to placebo with or without standard of care (nintedanib or pirfenidone) in subjects with idiopathic pulmonary fibrosis (IPF) Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Cudetaxestat (BLD-0409)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
No sites listed yet
Study dates
31 May 2022to 31 Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be eligible for participation in this study, subjects must meet all the following:
  • Age
  • At least 40 to 85 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
  • Type of Subject and Disease Characteristics
  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) as defined by ATS/ERS/JRS/ALAT guidelines.
  • IPF diagnosis within the past 7 years, with onset defined as the date of the first recorded diagnosis of IPF by HRCT and/or surgical biopsy or other appropriate tissue sample (e.g., cryobiopsy) in the medical history.
Show all 17Show fewer
  • Interstitial pulmonary fibrosis defined by HRCT scan at Screening, with evidence of ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing, within the whole lung. NOTE: HRCT scans will be assessed locally by the investigator prior to randomization. If a recent HRCT scan (within 3 months prior to Screening) is available, it can be utilized for screening purposes.
  • Observed time to disease progression (FVCpp) value >45% and <95% at Screening and Day 1 (prior to randomization).
  • Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted and corrected by hemoglobin (Hb) value ≥25% and ≤90% at Screening (determined locally). If a DLCO is available within 3 months prior to Screening, it can be utilized for screening purposes. NOTE: Both FVC and DLCO testing must be representative of the IPF underlying disease (i.e., have been obtained in absence of an acute respiratory event [e.g., lung infection, cold]) or other events that are known to affect pulmonary function test (PFT) results (e.g., broken rib, chest pain, other).
  • Contraception Related Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Male subjects with partners of childbearing potential must use condom and female subjects of childbearing potential (including those <1 year postmenopausal) must use a highly effective method of contraception per Clinical Trial Facilitation Group (CTFG) recommendation during the conduct of the study, and for 30 days after the last dose of IP (males only during exposure to IP).
  • Women not of childbearing potential are defined as:
  • Post-menopausal women (defined as at least 12 months with no menses without an alternative medical cause); in women < 45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; OR
  • Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion, at least 6 weeks prior to Screening; OR
  • Have a congenital or acquired condition that prevents childbearing. Informed Consent
  • Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protocol Other
  • Treatment with approved background IPF therapy such as nintedanib or pirfenidone will be allowed as long as subjects are on a stable dose for at least 12 weeks prior to the first dose of the Investigational product and throughout the treatment period.

Who cannot join

  • Subjects meeting any of the following exclusion criteria are not eligible to be randomized into the study:
  • Medical Conditions
  • Evidence of significant obstructive lung disease by any of the following criteria: (1) forced expiratory volume in 1 second (FEV1)/FVC) ratio <0.70, or (2) extent of emphysema greater than the extent of fibrosis on HRCT. NOTE: This requires confirmation by the investigator prior to randomization.
  • Interstitial lung disease (ILD) other than IPF, including but not limited to any of the other types of idiopathic interstitial pneumonias; lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis, infectious diseases, and connective tissue diseases. In cases of uncertain diagnosis, serological testing and/or review by multi-disciplinary team should be performed to confirm diagnosis of IPF vs. other types of ILD.
  • Sustained improvement in the severity of IPF during the 12 months prior to Screening, based on changes in FVC, DLCO, and/or HRCT scans of the chest.
  • History of other types of respiratory diseases, including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the investigator, would impact the primary protocol endpoint or otherwise preclude the subject's participation in the study.
Show all 35Show fewer
  • History of liver dysfunction including patients with moderate (Child Pugh B) or severe (Child Pugh C) impairment or disordered coagulation.
  • Medical conditions (e.g., myocardial infarction/stroke within the past 6 months), or logistical challenges that in the opinion of the investigator preclude the subject's adequate participation in the study.
  • Poorly controlled chronic heart failure (New York Heart Association Class 3 or above); clinical diagnosis of cor pulmonale requiring specific treatment; or severe pulmonary arterial hypertension requiring specific treatment that, in the opinion of the investigator, would preclude the subject's participation in the study.
  • Ongoing acute IPF exacerbation, or suspicion of such process during Screening or randomization, including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during Screening.
  • High likelihood of lung transplantation (in the opinion of the Investigator) within 6 months after Day 1.
  • Body weight less than 40 kg (88.18 lb) or anorexia.
  • Any condition (other than IPF) that is likely to result in the death of the subject within the next year.
  • Any current malignancy (this does not include localized cancer such as basal or squamous cell carcinoma of skin). Any history of malignancy likely to result in mortality or requiring significant medical or surgical intervention within the next year.
  • The investigator judges that the subject will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, addiction, or any other relevant medical or psychiatric conditions.
  • Female subjects who are pregnant or breastfeeding.
  • Diagnostic Assessments
  • The following laboratory parameters are excluded:
  • Hb <10 g/dL (100 g/L)
  • White blood cells (WBC) <3000/μL (<3000/mm3)
  • Platelet count <70,000/μL (<70,000/mm3)
  • Serum creatinine ≥1.5 x upper limit of normal (ULN)
  • Glomerular filtration rate (GFR) < 60ml/m/1.73 or evidence of acute kidney injury
  • Serum total bilirubin >1.5 x ULN
  • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN, or serum alkaline phosphatase ≥2 x ULN.
  • Excluded Therapies
  • Daily use of phosphodiesterase type 5 (PDE-5) inhibitor drugs (e.g., sildenafil, tadalafil) except for treatment of severe pulmonary artery hypertension
  • Use of any therapeutics with strong inhibitors and strong inducers of CYP3A4 or CYP2C8 [e.g., rifampicin, ketoconazole, phenytoin, ritonavir, macrolide antibiotics (e.g., telithromycin), and carbamazepine] is also prohibited.
  • Prior/Concurrent Clinical Study Experience
  • Previous exposure to cudetaxestat
  • Use of any investigational drugs or unapproved therapies, or participation in a clinical study with an investigational new drug, within 30 days prior to first Screening visit.
  • Other Exclusions
  • History of allergic or anaphylactic reaction to cudetaxestat, or to any component of the excipient.
  • History of intolerance to nintedanib or pirfenidone (e.g., arterial thromboembolic disease, bleeding, proteinuria, or photosensitivity)
  • Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study

Trial locations and contacts

No sites are listed yet.

Chandarani Shinde contact

(650) 278 4291

respirare@blademed.com

About this study

Official title: RESPIRARE - A Phase 2, Randomized, Double-blinded, Placebo-controlled, Efficacy and Safety Study of Cudetaxestat (BLD-0409) Assessed Across Three Dose Ranges With or Without Standard of Care (Nintedanib or Pirfenidone) in Patients With Idiopathic Pulmonary Fibrosis (IPF)

The overall objective of this study is to evaluate the effectiveness and safety of cudetaxestat (BLD-0409) as compared to placebo with or without standard of care (nintedanib or pirfenidone) in subjects with idiopathic pulmonary fibrosis (IPF)

Read the detailed description

This is a phase 2, randomized, double-blinded, placebo-controlled, efficacy and safety study of cudetaxestat (BLD-0409) assessed across three dose ranges with or without standard of care (nintedanib or pirfenidone) in patients with idiopathic pulmonary fibrosis (IPF). The study will include a screening period, a treatment period, and a follow-up period.

Being tested
Cudetaxestat (BLD-0409), Control: Matching Placebo
Keywords
IPF, Lung Fibrosis
Medical subject headings
Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cudetaxestat (BLD-0409)Drug

    Also called Cudetaxestat

    Cudetaxestat - 250mg tablets (orally)

  • Control: Matching PlaceboDrug

    Placebo - 250mg tablets (orally)

Study groups in NCT05373914
Study groupRoleWhat they receive
Cudetaxestat (BLD-0409) 250mg once dailyExperimental250mg once daily (orally) with food
Receives: Drug: Cudetaxestat (BLD-0409); Drug: Control: Matching Placebo
Cudetaxestat (BLD-0409) 500mg dailyExperimental500mg once daily (orally) with food
Receives: Drug: Cudetaxestat (BLD-0409); Drug: Control: Matching Placebo
Cudetaxestat (BLD-0409) 500mg twice dailyExperimental500mg twice daily (orally) with food
Receives: Drug: Cudetaxestat (BLD-0409)
Matching Placebo twice dailyPlacebo comparatorMatching placebo twice daily (orally) with food
Receives: Drug: Control: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Observed changes in FVC (L) from Baseline to Week 26

    Change in Forced Vital Capacity FVC (L) from Baseline to Week 26.

    Measured: Up to 182 days

Secondary outcomes (4)

  1. Observed time to disease progression (FVCpp) decline of ≥10% or death

    Time to disease progression

    Measured: Up to 182 days

  2. Observed time to disease progression (FVCpp) decline of ≥5% or death

    Time to disease progression.

    Measured: Up to 182 days

  3. Observed changes in Quantitative Lung Fibrosis (QLF) from Baseline to Week 26

    Assessed by high-resolution computed tomography (HRCT)

    Measured: Up to 182 days

  4. Incidence, nature and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events (SAEs)

    Safety and tolerability will be assessed based on the incidence, nature and severity of TEAEs and SAEs, and changes in safety laboratories, vitals and ECGs

    Measured: Up to 182 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2022
  2. Study start31 May 2022 (estimated)
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion31 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05373914
Sponsor's protocol ID
B-0409-201
Status last verified
May 2022
First submitted
10 May 2022
Last updated
18 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cudetaxestat (BLD-0409) in people with Idiopathic Pulmonary Fibrosis, run by Blade Therapeutics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chandarani Shinde ((650) 278 4291, respirare@blademed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observed changes in FVC (L) from Baseline to Week 26 (time frame: Up to 182 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05373914.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in