Idiopathic Pulmonary FibrosisPhase 2NCT04244825
Safety, Pharmacodynamics, and Pharmacokinetics of Orally Administered BLD-2660 in Subjects With IPF
A Phase 2 study testing BLD-2660 in people with Idiopathic Pulmonary Fibrosis, run by Blade Therapeutics at 1 site in United Kingdom.
Trial summary
A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects with Idiopathic Pulmonary Fibrosis Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- BLD-2660
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Dec 2019to 5 Nov 2020
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for inclusion into this study, each subject must fulfill the following inclusion criteria within 20 days prior to Randomization on Day 1:
- Age and Gender
- Male subjects 45 years of age and over, or female subjects 50 years of age and over, at the time of signing the informed consent.
- Diagnosis and disease characteristics
- Subjects with diagnosis of IPF as defined by the American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of Idiopathic Interstitial Pneumonia.
- Forced vital capacity (FVC) >45% predicted and diffusing capacity of the lung for carbon monoxide (DLCO) >30% predicted.
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- Alanine aminotransferase (ALT) within normal limit (WNL).
- Aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤1.2× upper limit of normal (ULN).
- Total bilirubin ≤ULN (isolated bilirubinemia ≤2× ULN is acceptable if direct bilirubin to total bilirubin ratio <0.35).
- Body mass index (BMI) up to 35 kg/m2 inclusive. Reproductive Considerations Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- All subjects (male or female) who are of childbearing potential must agree to use highly effective contraception during the study.
- Male subjects and female partners of male subjects must continue to use highly effective contraception for 90 days after the last dose of study drug (see Medicines and Healthcare products Regulatory Agency, 2019 for further guidance regarding highly effective contraception). Male subjects must agree not to donate sperm for 90 days after last dose of study drug.
- Female subjects and male partners of female subjects must continue to use highly effective contraception for 60 days after the last dose of study drug. Female subjects should not donate oocytes during this time.
- Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day (-1). Women of childbearing potential (WOCBP) must agree to undergo pregnancy testing at regular intervals throughout the study.
- Female subjects not of childbearing potential as defined by being postmenopausal (with cessation of regular menstrual periods for at least 1 year), confirmed by follicle stimulating hormone (FSH) level, or be surgically sterile.
- Informed Consent
- Subjects must provide signed informed consent prior to study entry and have the ability and willingness to attend and comply with the necessary visits at the study site.
Who cannot join
- To be eligible for inclusion into this study, each subject must violate none of the following exclusion criteria within 20 days prior to Randomisation on Day 1.
- Medical Conditions
- Recent (less than 6 weeks) significant wound (in the opinion of the Investigator), or presence of an ongoing non-healing skin wound or ulcer.
- Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will complete the study per protocol.
- Active infection (diagnosed or suspected) or history of recurrent infections, including but is not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, cellulitis or chronic ongoing infectious disease within 4 weeks prior to first dose of study drug. Note: Rescreening will be permitted after 28 days if an infection leads to screening failure.
- Active malignancy and/or history of malignancy in the past 5 years, except for non-melanoma skin cancer, carcinoma in situ of the breast that has been successfully treated, carcinoma in situ of the cervix that has been successfully treated, early stage, untreated prostate cancer, or prostate cancer with completion of treatment >2 years prior to Screening.
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- Extensive chronic obstructive pulmonary disease (where extent of emphysema >extent of fibrosis on computerised tomography (CT) scan or FEV1: FVC ratio <0.65).
- Other explanation for lung fibrosis, including but not limited to radiation, sarcoidosis, bronchiolitis obliterans organizing pneumonia, collagen vascular disease, hypersensitivity pneumonitis, etc.
- IPF exacerbation within last 60 days.
- A history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subjects' participation for the full duration of the study, or is not in the best interest of the subjects to participate, in the opinion of the Investigator.
- Diagnostic Assessments
- Positivity for Human Immunodeficiency Virus (HIV) antibody (HIV-1 and/or HIV-2) and/or HIV-1 p24 antigen.
- Positivity for Hepatitis C virus antibody (HCV Ab or anti-HCV) and/or Hepatitis B surface antigen (HBsAg).
- Absolute neutrophil count <1700/µL.
- Significant hypoxia, requiring >2 L/min oxygen to maintain a resting oxygen saturation >89%.
- Poor exercise tolerance.
- Serum troponin I level >ULN.
- Prior/Concomitant Therapy
- Use of anticoagulants that prolong Prothrombin time (PT)/International normalised ratio (INR).
- Use of anticoagulants within 2 days of Day (-1) (bronchoscopy). Note: The subjects who cannot discontinue the anticoagulants within 2 days of Day (-1) bronchoscopy will be excluded.
- Treatment with any anti-fibrotic therapy (pirfenidone or nintedanib) within 30 days of Screening.
- Immunosuppressive therapy within 3 months prior to first dose of study drug (unless for non-IPF indication).
- Use of oral steroids >10 mg/day (or prednisolone equivalent). Note: If the subject is on steroid dose equivalent to 10 mg/day prednisone or more, the Investigator may decide if the tapering down to the dose of 10 mg/day prednisone is possible and safe.
- Start of new biologic or change in biologic dose within 24 weeks prior to Day 1.
- Cyclophosphamide within 6 months prior to the first dose of study drug (unless for other indication).
- Prior/Concurrent Clinical Study Experience
- Administration of another investigational product, investigational device, or approved therapy for investigational use within 30 days prior to the first study drug administration, or five half-lives, whichever is longer.
- Other Exclusions
- Blood donation or significant blood loss within 60 days prior to the first study drug administration.
- Plasma donation within 7 days prior to the first study drug administration.
- Female subjects who are pregnant or breastfeeding.
- History or presence of alcohol or drug abuse (including recreational marijuana use) within the 2 year prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period.
- Active smoker, smoking history or vaping within 4 weeks prior to the first dose of study drug. Subjects only using Nicotine replacement therapy (NRT) may be allowed per discretion of the Investigator.
- Subjects with an allergy to BLD-2660 or inactive components of BLD-2660.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects With Idiopathic Pulmonary Fibrosis
A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects with Idiopathic Pulmonary Fibrosis
Read the detailed description
This is a Phase 2a, double-blind, placebo-controlled, multicentre, adaptive design study of BLD-2660 in subjects with IPF. The study will include a Screening period, a Treatment period, and a Follow-up period. Data on PK, PD, and biomarker activity will be observed.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- BLD-2660, Control: Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLD-2660Drug
BLD-2660 - 150 mg capsules '00' size (PO) BID
Control: PlaceboDrug
Placebo - 150 mg capsules '00' size (PO) BID
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a BLD-2660 | Experimental | 900 mg (6 x 150 mg capsules) BID Receives: Drug: BLD-2660 |
| Cohort 1b BLD-2660 | Experimental | 900 mg (6 x 150 mg capsules) BID (Optional) Receives: Drug: BLD-2660 |
| Cohort 2 BLD-2660 | Experimental | 600 mg (4 x 150 mg capsules) BID Receives: Drug: BLD-2660 |
| Cohort 3 BLD-2660 | Experimental | 300 mg (2 x 150 mg capsules) BID Receives: Drug: BLD-2660 |
| Cohort 1a Placebo | Placebo comparator | 900 mg (6 x 150 mg capsules) BID Receives: Drug: Control: Placebo |
| Cohort 1b Placebo | Placebo comparator | 900 mg (6 x 150 mg capsules) BID (Optional) Receives: Drug: Control: Placebo |
| Cohort 2 Placebo | Placebo comparator | 600 mg (4 x 150 mg capsules) BID Receives: Drug: Control: Placebo |
| Cohort 3 Placebo | Placebo comparator | 300 mg (2 x 150 mg capsules) BID Receives: Drug: Control: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed changes in ILK from baseline
Change in RLU of BAL fluid analyzed by ILK-targeting ELISA assay. Analysis of difference in RLU correlates to change in cellular ILK from baseline.
Measured: 58 days
Observed changes in spectrin from baseline
Change in RLU of BAL fluid analyzed by spectrin-targeting ELISA assay. Analysis of difference in RLU correlates to change in cellular spectrin from baseline.
Measured: 58 days
Observed changes in ezrin from baseline
Change in RLU of BAL fluid analyzed by ezrin-targeting ELISA assay. Analysis of difference in RLU correlates to change in cellular ezrin from baseline.
Measured: 58 days
Observed changes in S100A9 from baseline
Change in RLU of BAL fluid analyzed by S100A9-targeting ELISA assay. Analysis of difference in RLU correlates to change in cellular S100A9 from baseline.
Measured: 58 days
Secondary outcomes (5)
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
Measured by plasma concentration
Measured: 58 days
AUC from time 0 to infinity (AUC0-inf)
Measured by plasma concentration
Measured: 58 days
Maximum observed drug concentration (Cmax)
Measured by plasma concentration
Measured: 58 days
Time of the maximum drug concentration (Tmax)
Measured by plasma concentration
Measured: 58 days
Incidence of Treatment-Emergent Adverse Events as assessed by PI and SMC
AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events.
Measured: 58 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start15 Dec 2019
- Primary completion14 Sep 2020
- Study completion5 Nov 2020
Why it stopped: Withdrawn due to concerns for patient safety during COVID-19 crisis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blade Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244825
- Sponsor's protocol ID
- B-2660-203
- Status last verified
- Mar 2021
- First submitted
- 3 Jan 2020
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT04244825
- Acronym / sponsor ID
- B-2660-203
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to concerns for patient safety during COVID-19 crisis
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Blade TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects with Idiopathic Pulmonary Fibrosis
Detailed description
This is a Phase 2a, double-blind, placebo-controlled, multicentre, adaptive design study of BLD-2660 in subjects with IPF. The study will include a Screening period, a Treatment period, and a Follow-up period. Data on PK, PD, and biomarker activity will be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a BLD-2660 | Experimental | Drug: BLD-2660900 mg (6 x 150 mg capsules) BID |
| Cohort 1b BLD-2660 | Experimental | Drug: BLD-2660900 mg (6 x 150 mg capsules) BID (Optional) |
| Cohort 2 BLD-2660 | Experimental | Drug: BLD-2660600 mg (4 x 150 mg capsules) BID |
| Cohort 3 BLD-2660 | Experimental | Drug: BLD-2660300 mg (2 x 150 mg capsules) BID |
| Cohort 1a Placebo | Placebo comparator | Drug: Control: Placebo900 mg (6 x 150 mg capsules) BID |
| Cohort 1b Placebo | Placebo comparator | Drug: Control: Placebo900 mg (6 x 150 mg capsules) BID (Optional) |
| Cohort 2 Placebo | Placebo comparator | Drug: Control: Placebo600 mg (4 x 150 mg capsules) BID |
| Cohort 3 Placebo | Placebo comparator | Drug: Control: Placebo300 mg (2 x 150 mg capsules) BID |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- To be eligible for inclusion into this study, each subject must fulfill the following inclusion criteria within 20 days prior to Randomization on Day 1:
- Age and Gender
- Male subjects 45 years of age and over, or female subjects 50 years of age and over, at the time of signing the informed consent.
- Diagnosis and disease characteristics
- Subjects with diagnosis of IPF as defined by the American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of Idiopathic Interstitial Pneumonia.
Key exclusion criteria (34 listed)
- To be eligible for inclusion into this study, each subject must violate none of the following exclusion criteria within 20 days prior to Randomisation on Day 1.
- Medical Conditions
- Recent (less than 6 weeks) significant wound (in the opinion of the Investigator), or presence of an ongoing non-healing skin wound or ulcer.
- Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will complete the study per protocol.
- Active infection (diagnosed or suspected) or history of recurrent infections, including but is not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, cellulitis or chronic ongoing infectious disease within 4 weeks prior to first dose of study drug. Note: Rescreening will be permitted after 28 days if an infection leads to screening failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLD-2660BLD-2660 - 150 mg capsules '00' size (PO) BID | Drug | Cohort 1a BLD-2660, Cohort 1b BLD-2660, Cohort 2 BLD-2660, Cohort 3 BLD-2660 |
| Control: PlaceboPlacebo - 150 mg capsules '00' size (PO) BID | Drug | Cohort 1a Placebo, Cohort 1b Placebo, Cohort 2 Placebo, Cohort 3 Placebo |
Primary outcome
Observed changes in ILK from baseline
Time frame: 58 days
Change in RLU of BAL fluid analyzed by ILK-targeting ELISA assay. Analysis of difference in RLU correlates to change in cellular ILK from baseline.
Observed changes in spectrin from baseline
Time frame: 58 days
Change in RLU of BAL fluid analyzed by spectrin-targeting ELISA assay. Analysis of difference in RLU correlates to change in cellular spectrin from baseline.
Observed changes in ezrin from baseline
Time frame: 58 days
Change in RLU of BAL fluid analyzed by ezrin-targeting ELISA assay. Analysis of difference in RLU correlates to change in cellular ezrin from baseline.
Observed changes in S100A9 from baseline
Time frame: 58 days
Change in RLU of BAL fluid analyzed by S100A9-targeting ELISA assay. Analysis of difference in RLU correlates to change in cellular S100A9 from baseline.
5 secondary outcomes
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
Time frame: 58 days
AUC from time 0 to infinity (AUC0-inf)
Time frame: 58 days
Maximum observed drug concentration (Cmax)
Time frame: 58 days
Time of the maximum drug concentration (Tmax)
Time frame: 58 days
Incidence of Treatment-Emergent Adverse Events as assessed by PI and SMC
Time frame: 58 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BLD-2660 in people with Idiopathic Pulmonary Fibrosis, run by Blade Therapeutics at 1 site in United Kingdom.
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 34 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: withdrawn, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed changes in ILK from baseline (time frame: 58 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2021.