Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000499482p
Ethics application status
Submitted, not yet approved
Date submitted
30/04/2025
Date registered
22/05/2025
Date last updated
22/05/2025
Date data sharing statement initially provided
22/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Silicosis Treatment with Infliximab – A Key Evaluation (STRIKE)
Scientific title
Silicosis Treatment with Infliximab – A Key Evaluation (STRIKE): a pilot study on the efficacy, feasibility and safety of infliximab in adults with complicated silicosis.
Secondary ID [1] 314325 0
Nil known
Universal Trial Number (UTN)
Trial acronym
STRIKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Silicosis 337292 0
Condition category
Condition code
Respiratory 333685 333685 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The STRIKE trial is a single-centre, investigator-initiated pilot study assessing the efficacy of infliximab in patients with artificial stone-associated complicated silicosis. Safety and feasibility will also be assessed. Currently there are no treatments available for silicosis.
Participants will receive 5 mg/kg intravenous infliximab at weeks 0, 2, and 6, followed by maintenance infusions every 6 weeks until week 24. Infusions will be administered by registered nursing staff at the Alfred Hospital Medical Day Unit (MDU), following existing hospital protocols for infliximab. Nursing staff will already have familiarity with infliximab as it is administered in the MDU for various other indications.
Adherence to this intervention will be assessed at clinical review at 6 weekly intervals (as written into the protocol) and confirmed by reviewing nursing notes on the electronic medical record. Attendance records for each participant will be logged in a trial spreadsheet for record-keeping.
Intervention code [1] 330942 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341481 0
Change in respiratory symptoms and health-related quality of life
Timepoint [1] 341481 0
Baseline, week 24 (after treatment), and week 52 (longer term, post treatment cessation)
Primary outcome [2] 341277 0
Change in lung function parameters
Timepoint [2] 341277 0
Baseline, week 24 (after treatment), and week 52 (longer term, post treatment cessation)
Primary outcome [3] 341480 0
Change in inflammatory activity
Timepoint [3] 341480 0
Baseline, week 24 (after treatment), and week 52 (longer term, post treatment cessation)
Secondary outcome [1] 447352 0
Change in lung fibrosis/parenchymal findings
Timepoint [1] 447352 0
Baseline, week 24 (after treatment)
Secondary outcome [2] 447001 0
Adverse event rates
Timepoint [2] 447001 0
At each clinical visit after treatment commences (Week 6, 12, 18, 24 and 52), and in between these visits via patient self-reporting or nursing staff notification during infliximab infusions.
Secondary outcome [3] 447350 0
Change in novel/exploratory biomarkers such as serum levels of interleukin-18, interleukin-2, interleukin-6, TSLP, TNF
Timepoint [3] 447350 0
Baseline, week 12 (after treatment has commenced, mid way) and week 24 (after treatment completed)
Secondary outcome [4] 447349 0
Change in inflammatory markers
Timepoint [4] 447349 0
Baseline, week 24 (after treatment), and week 52 (longer term, post treatment cessation)

Eligibility
Key inclusion criteria
We will recruit 20 adults from the Alfred Hospital Occupational Respiratory Clinic with complicated silicosis caused by artificial stone-associated silica exposure, and with evidence of lung function decline. People from culturally and linguistically diverse backgrounds will be eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) ongoing potential exposure to silica (i.e. still working in the stone benchtop industry),
(ii) vaccination with live or bacterial vaccines within the prior 3 months,
(iii) active or untreated latent tuberculosis,
(iv) serious infections in the last 6 months (such as sepsis, abscess or severe opportunistic infections),
(v) history of recurrent infection,
(vi) history of severe hypersensitivity to infliximab, to other murine proteins or to any excipient of the product,
(vii) history of chronic liver disease,
(viii) history of severe cytopaenias,
(ix) history of demyelinating disease e.g. multiple sclerosis
(x) history of malignancy or lymphoproliferative disease within the last 5 years,
(xi) current or recent (<4 weeks) use of immunosuppression,
(xii) history of heart failure as determined on transthoracic echocardiography, including either left and right heart dysfunction
(xiii) pregnancy or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27864 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 44059 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 318844 0
Hospital
Name [1] 318844 0
The Alfred Health Department of Respiratory Medicine, The Alfred Hospital
Country [1] 318844 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Country
Australia
Secondary sponsor category [1] 321303 0
None
Name [1] 321303 0
Address [1] 321303 0
Country [1] 321303 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317461 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317461 0
Ethics committee country [1] 317461 0
Australia
Date submitted for ethics approval [1] 317461 0
20/03/2025
Approval date [1] 317461 0
Ethics approval number [1] 317461 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141110 0
Dr Ryan Hoy
Address 141110 0
Alfred Health, 55 Commercial Rd, Melbourne, VIC 3004
Country 141110 0
Australia
Phone 141110 0
+61 3 9076 7617
Fax 141110 0
Email 141110 0
[email protected]
Contact person for public queries
Name 141111 0
Ryan Hoy
Address 141111 0
Alfred Health, 55 Commercial Rd, Melbourne, VIC 3004
Country 141111 0
Australia
Phone 141111 0
+61 3 9076 7617
Fax 141111 0
Email 141111 0
[email protected]
Contact person for scientific queries
Name 141112 0
Ryan Hoy
Address 141112 0
Alfred Health, 55 Commercial Rd, Melbourne, VIC 3004
Country 141112 0
Australia
Phone 141112 0
+61 3 9076 7617
Fax 141112 0
Email 141112 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Journal publication or its supplementary materials: Once publication of main results has occurred, contact details will be available on the relevant journal article.
For data sharing queries in the interim, requests may be made to PI Dr Ryan Hoy ([email protected]) or SI Dr Tiffany Lin ([email protected])

Are there extra considerations when requesting access to individual participant data?
Yes: Institutional policies on data sharing



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    STRIKE_StudyProtocol_v3_7.4.25_clean.docx
Informed consent form    STRIKE_PICF_v2.1_28.4.25_clean.docx


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.