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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04647890




Registration number
NCT04647890
Ethics application status
Date submitted
16/11/2020
Date registered
1/12/2020

Titles & IDs
Public title
Effects of FT011 in Systemic Sclerosis
Scientific title
A Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic Sclerosis
Secondary ID [1] 0 0
CER-FT011-SSc01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scleroderma, Systemic 0 0
Scleroderma, Diffuse 0 0
Sclerosis, Systemic 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FT011
Treatment: Drugs - FT011
Treatment: Drugs - Placebo

Experimental: FT011 200mg - 200mg once daily for 12 weeks

Experimental: FT011 400mg - 400mg once daily for 12 weeks

Placebo comparator: Placebo - Placebo once daily for 12 weeks


Treatment: Drugs: FT011
Two x 100mg capsules once daily for 12 weeks

Treatment: Drugs: FT011
Two x 200mg capsules once daily for 12 weeks

Treatment: Drugs: Placebo
Two placebo capsules once daily for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
FT011 Levels in Plasma
Timepoint [1] 0 0
Mean of cmax post first dose and cmax post last dose
Primary outcome [2] 0 0
FT011 Levels in Plasma
Timepoint [2] 0 0
Mean of time to cmax post first dose and time to cmax post last dose
Primary outcome [3] 0 0
FT011 Levels in Plasma
Timepoint [3] 0 0
Mean of AUC hours post first dose and AUC hours post last dose
Secondary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From Baseline to End of Study
Timepoint [1] 0 0
Baseline to Week 16
Secondary outcome [2] 0 0
mRSS Change From Baseline
Timepoint [2] 0 0
End of treatment (week 12)
Secondary outcome [3] 0 0
%FVC Change From Baseline
Timepoint [3] 0 0
End of treatment (Week 12)
Secondary outcome [4] 0 0
Physician Global Assessment Change From Baseline
Timepoint [4] 0 0
End of treatment (Week 12)
Secondary outcome [5] 0 0
Patient Global Assessment Change From Baseline
Timepoint [5] 0 0
End of treatment (Week 12)
Secondary outcome [6] 0 0
Scleroderma HAQ-DI Change From Baseline
Timepoint [6] 0 0
End of treatment (Week 12)
Secondary outcome [7] 0 0
Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Scleroderma Clinical Trial Consortium Damage Index (SCTC-DI) Change From Baseline
Timepoint [8] 0 0
End of treatment (Week 12)
Secondary outcome [9] 0 0
5-D Itch Scale Change From Baseline
Timepoint [9] 0 0
End of treatment (Week 12)

Eligibility
Key inclusion criteria
1. Provide written informed consent prior to any study procedures and who agree to adhere to all protocol requirements.
2. Aged 18 to 75 years inclusive at the time of consent.
3. Have a classification of systemic sclerosis, as defined by American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria with disease duration =10 years from first non-Raynaud phenomenon manifestation.
4. Have a diagnosis of diffuse cutaneous SSc defined as systemic sclerosis with skin thickening on the upper arms proximal to the elbows, on the upper legs proximal to the knees, or on the trunk.
5. Have skin thickening in a body area suitable for repeat biopsy.
6. Have a mRSS at Screening of =15 to =40.
7. FVC =50% of predicted at Screening.
8. If on azathioprine, mycophenolate mofetil, or hydroxychloroquine, have been on a stable dose for at least 2 months prior to baseline.
9. Women of childbearing potential (WOCPB) and males with partners of child-bearing potential must agree to use highly effective contraception (a failure rate of <1%), for the duration of the study and until three months after their last dose of IMP.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant or breast-feeding, or plan to become pregnant during the study.
2. Have received any IMP within 30 days or 5 half-lives prior to randomisation (4 months if the previous drug was a new chemical entity), whichever is longer.
3. Have known or suspected contraindications to the IMP.
4. Have severe or unstable SSc or end-stage organ involvement as evidenced by:

1. On an organ transplantation list or has received an organ transplant including autologous stem cell transplant.
2. Renal crisis within 1 year prior to Baseline.
5. Interstitial lung disease or pulmonary hypertension requiring constant oxygen therapy. This excludes oxygen used to aid sleep or exercise.
6. Gastrointestinal dysmotility requiring total parenteral nutrition or requiring hospitalisation within the 6 months prior to Baseline.
7. Concomitant inflammatory myositis, rheumatoid arthritis, or systemic lupus erythematosus when definite classification criteria for those diseases are met (Bohan and Peter criteria for polymyositis and dermatomyositis)
8. SSc-like illnesses related to exposures or ingestions
9. The use of the following drugs within the specified periods:

1. Methotrexate in the 2 weeks prior to Day 1
2. Other anti-fibrotic agents including D-penicillamine or tyrosine kinase inhibitors (nilotinib, imatinib, dasatinib) in the month prior to Screening.
3. Biologic drugs such as tumour necrosing factor (TNF) inhibitors, tocilizumab, or Janus kinase (JAK) inhibitors, in the 3 months prior to Screening.
4. Rituximab in the 6 months prior to Screening.
5. Cyclophosphamide oral or IV in the 3 months prior to Screening.
6. Oral prednisolone >10 mg per day or IV steroids in the month prior to Screening.
10. Have any malignancy not considered cured (except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix); a subject is considered cured if there has been no evidence of cancer recurrence for the 6 years prior to randomisation.
11. Have aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), lactate dehydrogenase (LDH), or bilirubin values above the upper limit of normal (ULN) at Screening or Baseline, or evidence of hepatic disease as determined by any one of the following: history of hepatic encephalopathy, history of oesophageal varices, or history of portacaval shunt.
12. Estimated glomerular filtration rate (eGFR) <60mL/min, urinary albumin/creatinine ratio >30mg/g.
13. Haemoglobin < 80 g/L, platelets < 90 x 109/L, or neutrophil count < 1.4 x 109/L
14. Other than SSc, have any other medical condition or significant co-morbidities, clinically relevant social or psychiatric conditions, or any finding during Screening, which in the investigator's opinion may put the subject at risk or interfere with the study objectives.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/11/2022
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
Netherlands
State/province [1] 0 0
Nijmegen
Country [2] 0 0
Poland
State/province [2] 0 0
Bydgoszcz
Country [3] 0 0
Poland
State/province [3] 0 0
Kraków
Country [4] 0 0
Poland
State/province [4] 0 0
Malbork
Country [5] 0 0
Poland
State/province [5] 0 0
Warsaw
Country [6] 0 0
Spain
State/province [6] 0 0
Barcelona
Country [7] 0 0
Ukraine
State/province [7] 0 0
Kyiv
Country [8] 0 0
Ukraine
State/province [8] 0 0
Poltava

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Certa Therapeutics
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Darren Kelly, PhD
Address 0 0
Certa Therapeutics Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04647890