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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04875754




Registration number
NCT04875754
Ethics application status
Date submitted
26/04/2021
Date registered
6/05/2021

Titles & IDs
Public title
A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis
Scientific title
A Phase 1/2a, Double-Blind, Placebo-Controlled Single Dose Escalation Study of Intra-Articular ICM 203 in Subjects With Kellgren-Lawrence Grade 2 or Grade 3 Osteoarthritis of the Knee
Secondary ID [1] 0 0
ICM 20-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ICM-203
Treatment: Drugs - Placebo

Experimental: Group 1: ICM-203 (Low dose) vs Placebo - 8 subjects will be randomized to receive a single intra-articular injection of ICM-203 at 6x10e12 vg (n=6) or placebo (n=2) into the target knee at Day 1

Experimental: Group 2: ICM-203 (Medium dose) vs Placebo - 4 subjects will be randomized to receive a single intra-articular injection of ICM-203 at 2x10e13 vg (n=3) or placebo (n=1) into the target knee at Day 1

Experimental: Group 3: ICM-203 (High dose) vs Placebo (Optional) - 4 subjects will be randomized to receive a single intra-articular injection of ICM-203 at 6x10e13 vg (n=3) or placebo (n=1) into the target knee at Day 1


Treatment: Other: ICM-203
Intra-articular injection

Treatment: Drugs: Placebo
Intra-articular injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to Week 52
Primary outcome [2] 0 0
Severity of Treatment-Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to Week 52
Secondary outcome [1] 0 0
Knee pain
Timepoint [1] 0 0
Up to Week 52
Secondary outcome [2] 0 0
Knee function
Timepoint [2] 0 0
Up to Week 52
Secondary outcome [3] 0 0
Analgesic use
Timepoint [3] 0 0
Up to Week 52
Secondary outcome [4] 0 0
Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)
Timepoint [4] 0 0
Up to Week 52
Secondary outcome [5] 0 0
Joint space width
Timepoint [5] 0 0
Up to Week 52
Secondary outcome [6] 0 0
Humoral response to AAV5.2 capsid
Timepoint [6] 0 0
Up to Week 52
Secondary outcome [7] 0 0
Cellular immune response to AAV5.2 capsid
Timepoint [7] 0 0
Up to Week 52
Secondary outcome [8] 0 0
Systemic biodistribution of ICM-203
Timepoint [8] 0 0
Up to Week 52

Eligibility
Key inclusion criteria
1. Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive, at the time of screening.
2. Kellgren-Lawrence grade 2 or grade 3 OA of target knee.
3. Target knee pain between 4 and 9, inclusive, on an NRS ranging from 0 (no pain) to 10 (worst pain imaginable).
4. KOOS function in daily living score >25, a measure of knee function ranging from 0 (extreme problems) to 100 (no problems).
5. A stable treatment regimen for symptomatic relief of OA, including NSAIDs, for 4 weeks prior to screening.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of rheumatoid arthritis, psoriatic arthritis, gout, pseudogout, autoimmune OA, chondrocalcinosis, hemochromatosis, villonodular synovitis, and synovial chondromatosis or other disorder that in the opinion of the Investigator could cause inflammation of the knee.
2. Injection of steroid, hyaluronate or other agent, into the target knee less than 90 days prior to day 1.
3. Major injury to the target knee, such as torn ligament or severe sprain, within 12 months of screening.
4. Disability so severe that the subject cannot comply with the study requirements, including knee symptoms that result in significant difficulty or inability to walk.
5. Surgery on the target knee within 180 days prior to day 1
6. Total knee arthroplasty or other knee surgery planned in the next 12 months.
7. Active joint infection or other concurrent medical (diabetes, uncontrolled hypertension, severe osteoporosis, glaucoma) or psychiatric condition that, in the opinion of the Investigator, would make the subject unsuitable for the study.

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
Other
Other design features
Phase
Phase 1
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
17/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ICM Biotech Australia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Alison Heald, MD
Address 0 0
ICM Co. Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alison Heald, MD
Address 0 0
Country 0 0
Phone 0 0
+1 206 465 3912
Fax 0 0
Email 0 0
alison.heald@icm-bio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04875754