IPFPhase 2NCT05349760
A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing AMB-05X in people with IPF, run by AmMax Bio, Inc..
Trial summary
AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- IPF
- What is being tested?
- AMB-05X
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥40 years old.
- History of confirmed diagnosis of IPF
- Chest HRCT at Screening
- Subjects who are either:
- Not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) or
- Being treated with approved IPF therapies (i.e., nintedanib or pirfenidone)
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- Has FVC ≥45% predicted of normal AND DLCO ≥25% and ≤90% predicted
- Has a FEV1/FVC ratio (Tiffeneau-Pinelli Index) ≥ 0.70
- Has adequate hematologic, hepatic, and renal function
Who cannot join
- Prior investigational drug use within 30 days or 5 half-lives
- Presence of emphysema exceeding the extent of fibrosis
- Active or anticipated need for lung transplant
- Treatment with prednisone
- Active cancer
- Active or chronic infection with HCV, HBV, or HIV
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- Known active tuberculosis
- History of or current immunosuppressive condition
- IPF exacerbation within 12 weeks
- Lower respiratory-tract infection requiring antibiotic therapy
- Smoking
- Other forms of interstitial lung disease
- History of lung volume reduction surgery or lung transplant
- Contraindications for forced expiratory maneuvers during spirometry
- Unstable cardiac or pulmonary disease (other than IPF)
- Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
- History of drug or alcohol abuse -
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.
- Conditions
- IPF
- Being tested
- AMB-05X, Placebo
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF
- 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.
AMB-05XBiological
A fully human monoclonal immunoglobulin (IgG2) directed against c-fms
PlaceboDrug
Saline/D5W
| Study group | Role | What they receive |
|---|---|---|
| AMB-05X | Experimental | AMB-05X will be administered every 4 weeks for 24 weeks (for 6 treatments in total). Receives: Biological: AMB-05X |
| Placebo | Placebo comparator | Placebo will be administered every 4 weeks for 24 weeks (for 6 treatments in total). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events
Frequency and severity of reported treatment-emergent adverse events will be graded per CTCAE 5-point scale
Measured: Week 24
Secondary outcomes (5)
Pulmonary Function
Change in forced vital (FVC) capacity in liters
Measured: Week 28
Pharmacodynamics via CSF1
Plasma CSF1 assessment and other exploratory biomarkers
Measured: Week 28
ST GEORGE'S RESPIRATORY QUESTIONNAIRE IDIOPATHIC PULMONARY FIBROSIS (SGRQ-I)
Change in health-related quality of life, as measured by St. George's Respiratory Questionnaire (SGRQ-I)
Measured: Week 28
Cmax
Peak Plasma Concentration (Cmax) measurement
Measured: Week 24
AUC
Area under the plasma concentration versus time curve (AUC) measurement
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study startMar 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: to focus resources on other studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies 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
- Model description
- 2:1 randomization of active to placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AmMax Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dorothy Nguyen, MD, Study director, AmMax Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349760
- Sponsor's protocol ID
- AMB-053-01
- Status last verified
- Jan 2023
- First submitted
- 31 Mar 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT05349760
- Acronym / sponsor ID
- AMB-053-01
- Conditions
- IPF
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: to focus resources on other studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmMax Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 27 Apr 2022 (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.
AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 2:1 randomization of active to placebo
| Arm | Type | Receives |
|---|---|---|
| AMB-05X | Experimental | Biological: AMB-05XAMB-05X will be administered every 4 weeks for 24 weeks (for 6 treatments in total). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered every 4 weeks for 24 weeks (for 6 treatments in total). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects ≥40 years old.
- History of confirmed diagnosis of IPF
- Chest HRCT at Screening
- Subjects who are either:
- Has FVC ≥45% predicted of normal AND DLCO ≥25% and ≤90% predicted
Key exclusion criteria (17 listed)
- Prior investigational drug use within 30 days or 5 half-lives
- Presence of emphysema exceeding the extent of fibrosis
- Active or anticipated need for lung transplant
- Treatment with prednisone
- Active cancer
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 |
|---|---|---|
| AMB-05XA fully human monoclonal immunoglobulin (IgG2) directed against c-fms | Biological | AMB-05X |
| PlaceboSaline/D5W | Drug | Placebo |
Primary outcome
Treatment-emergent adverse events
Time frame: Week 24
Frequency and severity of reported treatment-emergent adverse events will be graded per CTCAE 5-point scale
5 secondary outcomes
Pulmonary Function
Time frame: Week 28
Pharmacodynamics via CSF1
Time frame: Week 28
ST GEORGE'S RESPIRATORY QUESTIONNAIRE IDIOPATHIC PULMONARY FIBROSIS (SGRQ-I)
Time frame: Week 28
Cmax
Time frame: Week 24
AUC
Time frame: Week 24
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 19 Jan 2023.
- 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.
Dorothy Nguyen, MD study director
AmMax Bio, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMB-05X in people with IPF, run by AmMax Bio, Inc..
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 9 inclusion and 17 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 19 Jan 2023. 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?
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?
Treatment-emergent adverse events (time frame: Week 24). 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 19 Jan 2023.