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FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This study is being conducted to see what the body does to the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FT011 200mg | Experimental | 200mg once daily for 12 weeks |
|
| FT011 400mg | Experimental | 400mg once daily for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT011 | Drug | Two x 100mg capsules once daily for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| FT011 Levels in Plasma | Measurement of maximum concentration (cmax) of FT011. First dose Cmax and last dose Cmax for each participant were averaged together to calculate a single mean Cmax for each treatment arm | Mean of cmax post first dose and cmax post last dose |
| FT011 Levels in Plasma | Measurement of time to cmax (tmax). First dose tmax and last dose tmax for each participant were averaged together to calculate a single mean tmax for each treatment arm | Mean of time to cmax post first dose and time to cmax post last dose |
| FT011 Levels in Plasma | Measurement of area under the concentration time curve (AUC). First dose AUC and last dose AUC for each participant were averaged together to calculate a single mean AUC for each active arm | Mean of AUC hours post first dose and AUC hours post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From Baseline to End of Study | TEAEs per arm during study treatment and follow up periods | Baseline to Week 16 |
| mRSS Change From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or breast-feeding, or plan to become pregnant during the study.
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.
Have known or suspected contraindications to the IMP.
Have severe or unstable SSc or end-stage organ involvement as evidenced by:
Interstitial lung disease or pulmonary hypertension requiring constant oxygen therapy. This excludes oxygen used to aid sleep or exercise.
Gastrointestinal dysmotility requiring total parenteral nutrition or requiring hospitalisation within the 6 months prior to Baseline.
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)
SSc-like illnesses related to exposures or ingestions
The use of the following drugs within the specified periods:
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.
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.
Estimated glomerular filtration rate (eGFR) <60mL/min, urinary albumin/creatinine ratio >30mg/g.
Haemoglobin < 80 g/L, platelets < 90 x 109/L, or neutrophil count < 1.4 x 109/L
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.
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| Name | Affiliation | Role |
|---|---|---|
| Darren Kelly, PhD | Certa Therapeutics Pty Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia | ||
| St Vincent's Hospital Melbourne |
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| ID | Title | Description |
|---|---|---|
| FG000 | FT011 200mg | 200mg once daily for 12 weeks FT011: Two x 100mg capsules once daily for 12 weeks |
| FG001 | FT011 400mg | 400mg once daily for 12 weeks FT011: Two x 200mg capsules once daily for 12 weeks |
| FG002 | Placebo | Placebo once daily for 12 weeks Placebo: Two placebo capsules once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FT011 200mg | 200mg once daily for 12 weeks FT011: Two x 100mg capsules once daily for 12 weeks |
| BG001 | FT011 400mg | 400mg once daily for 12 weeks FT011: Two x 200mg capsules once daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | FT011 Levels in Plasma | Measurement of maximum concentration (cmax) of FT011. First dose Cmax and last dose Cmax for each participant were averaged together to calculate a single mean Cmax for each treatment arm | Placebo participants not tested | Posted | Mean | Standard Deviation | ug/mL | Mean of cmax post first dose and cmax post last dose |
|
Over the duration of the study period (12 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FT011 200mg | 200mg once daily for 12 weeks FT011: Two x 100mg capsules once daily for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharangytis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Darren Kelly, CEO | Certa Therapeutics Pty Ltd | +61 3 9657 0700 | dkelly@certatherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2021 | Aug 21, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2022 | Aug 21, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C576235 | FT011 |
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| FT011 |
| Drug |
Two x 200mg capsules once daily for 12 weeks |
|
| Placebo | Drug | Two placebo capsules once daily for 12 weeks |
|
The mRSS is a validated physical evaluation of patient's skin thickness rated by clinical palpation using a 0-3 scale (0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch the skin into a fold) for each of 17 surface anatomic areas of the body: face, anterior chest, abdomen, and, with right and left sides of the body separately evaluated, the fingers, forearms, upper arms, thighs, lower legs, dorsum of hands and feet. Individual values are summed and defined as the total skin score. Total score is 0 to 51 with higher scores indicating worse symptomology
| End of treatment (week 12) |
| %FVC Change From Baseline | Percent predicted FVC is calculated using equations incorporating age, gender, and race. It is calculated as (FVC Observed / FVC predicted) x 100, where FVC predicted is calculated relative to a reference population | End of treatment (Week 12) |
| Physician Global Assessment Change From Baseline | The physician's assessment of the patient's SSc status will be scored on a 100-mm horizontal VAS, ranging from 0 on the extreme left end of the scale indicating "no disease activity" (symptom free), and 100 on the extreme right end indicating "worst imaginable disease activity". | End of treatment (Week 12) |
| Patient Global Assessment Change From Baseline | The Patient's Global Assessment represents the patient's overall assessment of current SSc status on a 100-mm horizontal VAS, ranging from 0 on the extreme left end of the scale indicating "no disease activity" (symptom free), and 100 on the extreme right end indicating "worst imaginable disease activity". | End of treatment (Week 12) |
| Scleroderma HAQ-DI Change From Baseline | The HAQ-DI consists of 20 questions referring to eight component sets consisting of dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored from 0 to 3. The eight scores of the eight sections are summed and divided by 8. The total score indicates the patient's self-assessed level of disability - higher scores indicate worse symptomology. A negative change from baseline indicates improvement. The Scleroderma HAQ (SHAQ) includes an additional five scleroderma-specific visual analogue scales (VAS), addressing overall disease activity, Raynaud's phenomenon, finger ulcers, breathing, and intestinal problems. A composite VAS score is not created nor are the individual VAS scores incorporated into the HAQ DI score. | End of treatment (Week 12) |
| Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Week 12 | CRISS components include modified Rodnan skin score (mRSS), forced vital capacity percent predicted (%FVC), Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index (HAQ-DI). The exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in these 5 components. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement | Week 12 |
| Scleroderma Clinical Trial Consortium Damage Index (SCTC-DI) Change From Baseline | The SCTC-DI is a 23-item composite damage index to quantify organ damage in systemic sclerosis (0-55 scale; moderate damage >5, severe damage>12) | End of treatment (Week 12) |
| 5-D Itch Scale Change From Baseline | The 5-D itch scale is a 23-item validated instrument used to measure five domains of chronic itch: duration, degree, direction, disability, and distribution. Scores range from 5 to 25, with higher scores indicating a higher severity of chronic itch. | End of treatment (Week 12) |
| Fitzroy |
| Victoria |
| 3065 |
| Australia |
| Certa SSc trial site | Nijmegen | Netherlands |
| Certa SSc trial site | Bydgoszcz | Poland |
| Certa SSc trial site | Krakow | Poland |
| Certa SSc trial site | Malbork | Poland |
| Certa SSc trial site | Warsaw | Poland |
| Certa SSc trial site | Barcelona | Spain |
| Certa SSc trial site | Kyiv | Ukraine |
| Certa SSc trial site | Poltava | Ukraine |
| BG002 | Placebo | Placebo once daily for 12 weeks Placebo: Two placebo capsules once daily for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 |
| Placebo |
Placebo once daily for 12 weeks Placebo: Two placebo capsules once daily for 12 weeks |
|
|
| Primary | FT011 Levels in Plasma | Measurement of time to cmax (tmax). First dose tmax and last dose tmax for each participant were averaged together to calculate a single mean tmax for each treatment arm | Placebo participants not tested | Posted | Mean | Standard Deviation | hours | Mean of time to cmax post first dose and time to cmax post last dose |
|
|
|
| Primary | FT011 Levels in Plasma | Measurement of area under the concentration time curve (AUC). First dose AUC and last dose AUC for each participant were averaged together to calculate a single mean AUC for each active arm | Placebo participants not tested | Posted | Mean | Standard Deviation | h*ug/mL | Mean of AUC hours post first dose and AUC hours post last dose |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From Baseline to End of Study | TEAEs per arm during study treatment and follow up periods | Posted | Count of Participants | Participants | Baseline to Week 16 |
|
|
|
| Secondary | mRSS Change From Baseline | The mRSS is a validated physical evaluation of patient's skin thickness rated by clinical palpation using a 0-3 scale (0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch the skin into a fold) for each of 17 surface anatomic areas of the body: face, anterior chest, abdomen, and, with right and left sides of the body separately evaluated, the fingers, forearms, upper arms, thighs, lower legs, dorsum of hands and feet. Individual values are summed and defined as the total skin score. Total score is 0 to 51 with higher scores indicating worse symptomology | Posted | Mean | Standard Deviation | score on a scale | End of treatment (week 12) |
|
|
|
| Secondary | %FVC Change From Baseline | Percent predicted FVC is calculated using equations incorporating age, gender, and race. It is calculated as (FVC Observed / FVC predicted) x 100, where FVC predicted is calculated relative to a reference population | Posted | Mean | Standard Deviation | percentage of FVC change | End of treatment (Week 12) |
|
|
|
| Secondary | Physician Global Assessment Change From Baseline | The physician's assessment of the patient's SSc status will be scored on a 100-mm horizontal VAS, ranging from 0 on the extreme left end of the scale indicating "no disease activity" (symptom free), and 100 on the extreme right end indicating "worst imaginable disease activity". | Posted | Mean | Standard Deviation | score on a scale | End of treatment (Week 12) |
|
|
|
| Secondary | Patient Global Assessment Change From Baseline | The Patient's Global Assessment represents the patient's overall assessment of current SSc status on a 100-mm horizontal VAS, ranging from 0 on the extreme left end of the scale indicating "no disease activity" (symptom free), and 100 on the extreme right end indicating "worst imaginable disease activity". | Posted | Mean | Standard Deviation | score on a scale | End of treatment (Week 12) |
|
|
|
| Secondary | Scleroderma HAQ-DI Change From Baseline | The HAQ-DI consists of 20 questions referring to eight component sets consisting of dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored from 0 to 3. The eight scores of the eight sections are summed and divided by 8. The total score indicates the patient's self-assessed level of disability - higher scores indicate worse symptomology. A negative change from baseline indicates improvement. The Scleroderma HAQ (SHAQ) includes an additional five scleroderma-specific visual analogue scales (VAS), addressing overall disease activity, Raynaud's phenomenon, finger ulcers, breathing, and intestinal problems. A composite VAS score is not created nor are the individual VAS scores incorporated into the HAQ DI score. | Posted | Mean | Standard Deviation | score on a scale | End of treatment (Week 12) |
|
|
|
| Secondary | Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Week 12 | CRISS components include modified Rodnan skin score (mRSS), forced vital capacity percent predicted (%FVC), Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index (HAQ-DI). The exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in these 5 components. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
|
|
| Secondary | Scleroderma Clinical Trial Consortium Damage Index (SCTC-DI) Change From Baseline | The SCTC-DI is a 23-item composite damage index to quantify organ damage in systemic sclerosis (0-55 scale; moderate damage >5, severe damage>12) | Posted | Mean | Standard Deviation | score on a scale | End of treatment (Week 12) |
|
|
|
| Secondary | 5-D Itch Scale Change From Baseline | The 5-D itch scale is a 23-item validated instrument used to measure five domains of chronic itch: duration, degree, direction, disability, and distribution. Scores range from 5 to 25, with higher scores indicating a higher severity of chronic itch. | Posted | Mean | Standard Deviation | score on a scale | End of treatment (Week 12) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 7 |
| 10 |
| EG001 | FT011 400mg | 400mg once daily for 12 weeks FT011: Two x 200mg capsules once daily for 12 weeks | 0 | 10 | 0 | 10 | 4 | 10 |
| EG002 | Placebo | Placebo once daily for 12 weeks Placebo: Two placebo capsules once daily for 12 weeks | 0 | 10 | 0 | 10 | 6 | 10 |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
|
| Genital candidiasis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
|
| Lower respiratory infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Escherichia test positive | Investigations | MedDRA 24.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Vocal cord disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Raynaud's phenomenon | Vascular disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
|
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