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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06132256




Registration number
NCT06132256
Ethics application status
Date submitted
9/11/2023
Date registered
15/11/2023
Date last updated
26/01/2024

Titles & IDs
Public title
Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Scientific title
A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Axatilimab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Secondary ID [1] 0 0
2022-502954-15-00
Secondary ID [2] 0 0
SNDX-6352-0506
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Axatilimab
Other interventions - Placebo

Experimental: Axatilimab - Participants will receive axatilimab every 2 weeks during the 26-week Treatment Period.

Placebo Comparator: Placebo - Participants will receive placebo every 2 weeks during the 26-week Treatment Period.


Treatment: Drugs: Axatilimab
Administered as intravenous (IV) infusion

Other interventions: Placebo
Placebo to match axatilimab administered as IV infusion. Placebo will not contain active ingredient.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL])
Timepoint [1] 0 0
Baseline through Week 26
Secondary outcome [1] 0 0
Time to disease progression
Timepoint [1] 0 0
Baseline through Week 26
Secondary outcome [2] 0 0
Annualized rate of decline in FVC percent predicted over 26 weeks
Timepoint [2] 0 0
Baseline through Week 26
Secondary outcome [3] 0 0
Change in St. George's Respiratory Questionnaire (SGRQ) score from Baseline to Week 26
Timepoint [3] 0 0
Baseline, Week 26
Secondary outcome [4] 0 0
Change in diffusion capacity for carbon monoxide (DLco % of predicted, corrected for hemoglobin) from Baseline to Week 26
Timepoint [4] 0 0
Baseline, Week 26

Eligibility
Key inclusion criteria
Key

- Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European
Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic
Society Clinical Practice Guideline (Raghu 2018).

- Chest high-resolution computed tomography (HRCT) performed within 12 months prior to
first Screening Visit and according to the minimum requirements for IPF diagnosis by
central review based on participant's HRCT only (if no lung biopsy is available) or
based on both HRCT and lung biopsy (with application of the different criteria in
either situation). If an evaluable HRCT <12 months prior to Screening is not
available, an HRCT can be performed at first Screening Visit to determine eligibility,
according to the same requirements as the historical HRCT. If a participant has an
indeterminate usual interstitial pneumonia (UIP) pattern and their HRCT is >6 months
old, if in the opinion of the Investigator their disease has progressed, an additional
HRCT may be obtained and reviewed for eligibility.

- FVC =45% of predicted normal at Screening Visits.

- Forced expiratory volume in 1 second (FEV1)/FVC =0.7 at Screening Visits.

- DLco =30% and =90% of predicted, corrected for hemoglobin at first Screening Visit.

Key
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Abnormalities detected on electrocardiogram (ECG) of either rhythm or conduction that
in the opinion of the Investigator are clinical significant. Participants with
implantable cardiovascular devices (for example, pacemaker) affecting the QT interval
time may be enrolled in the study based upon Investigator judgment following
cardiologist consultation if deemed necessary, and only after discussion with the
Medical Monitor.

- Emphysema present on =50% of the HRCT, or the extent of emphysema is greater than the
extent of fibrosis, according to central review of the HRCT.

- Interstitial lung disease associated with known primary diseases (for example,
connective tissue disease, sarcoidosis and amyloidosis), exposures (for example,
radiation, silica, asbestos, and coal dust), or drugs (for example, amiodarone).

- Participants who cannot meet protocol-specified baseline stability criteria.

- Acute IPF exacerbation within 3 months prior to screening.

- Receiving nintedanib in combination with pirfenidone

- Receiving systemic corticosteroids equivalent to prednisone >10 milligrams (mg)/day or
equivalent within 2 weeks prior to Screening.

- Use of any of the following therapies within 4 weeks prior to Screening and during the
Screening Period, or planned during the study: imatinib, ambrisentan, azathioprine,
mycophenolate mofetil, cyclophosphamide, cyclosporine A, tacrolimus, bosentan,
methotrexate, inhaled treprostinil, phosphodiesterase-5 inhibitors, including
sildenafil (unless for occasional use), prednisone at steady dose >10 mg/day or
equivalent, or other investigational therapy.

- History of cigarette smoking or vaping within the previous 3 months.

- Female participant who is pregnant or breastfeeding.

- Previous exposure to study intervention or known allergy/sensitivity to study drug.

- Receiving an investigational treatment within 28 days of randomization.

- Inadequate IV access.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
135
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Wallace Street Specialist Centre - Brisbane
Recruitment hospital [2] 0 0
Institute for Respiratory Health - Nedlands
Recruitment postcode(s) [1] 0 0
4032 - Brisbane
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Syndax Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
DevPro Biopharma
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study will evaluate the efficacy and safety of axatilimab in participants with IPF.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06132256
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Syndax Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
781-419-1400
Fax 0 0
Email 0 0
clinicaltrials@syndax.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06132256