Effects of FT011 in Systemic Sclerosis

NCT04647890 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CER-FT011-SSc01
• Study Type: interventional
• Target: 30
• Locations: 5 countries
• Sites: 10

Brief Summary

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).

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis, Systemic

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (9)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From Baseline to End of Study

  Baseline to Week 16

• mRSS Change From Baseline

  End of treatment (week 12)

• %FVC Change From Baseline

  End of treatment (Week 12)

• Physician Global Assessment Change From Baseline

  End of treatment (Week 12)

• Patient Global Assessment Change From Baseline

  End of treatment (Week 12)

Study Arms (3)

FT011 200mg

EXPERIMENTAL

200mg once daily for 12 weeks

Drug: FT011

FT011 400mg

EXPERIMENTAL

400mg once daily for 12 weeks

Drug: FT011

Placebo

PLACEBO COMPARATOR

Placebo once daily for 12 weeks

Drug: Placebo

Interventions

FT011 DRUG

Two x 100mg capsules once daily for 12 weeks

FT011 200mg

Placebo DRUG

Two placebo capsules once daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent prior to any study procedures and who agree to adhere to all protocol requirements.
• Aged 18 to 75 years inclusive at the time of consent.
• 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.
• 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.
• Have skin thickening in a body area suitable for repeat biopsy.
• Have a mRSS at Screening of ≥15 to ≤40.
• FVC ≥50% of predicted at Screening.
• If on azathioprine, mycophenolate mofetil, or hydroxychloroquine, have been on a stable dose for at least 2 months prior to baseline.
• 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.

You may not qualify if:

• 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:
• On an organ transplantation list or has received an organ transplant including autologous stem cell transplant.
• Renal crisis within 1 year prior to Baseline.
• 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:
• Methotrexate in the 2 weeks prior to Day 1
• Other anti-fibrotic agents including D-penicillamine or tyrosine kinase inhibitors (nilotinib, imatinib, dasatinib) in the month prior to Screening.
• Biologic drugs such as tumour necrosing factor (TNF) inhibitors, tocilizumab, or Janus kinase (JAK) inhibitors, in the 3 months prior to Screening.
• Rituximab in the 6 months prior to Screening.

Sponsors & Collaborators

• Certa Therapeutics: lead

Study Sites (10)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Certa SSc trial site

Nijmegen, Netherlands

Location

Certa SSc trial site

Bydgoszcz, Poland

Location

Certa SSc trial site

Krakow, Poland

Location

Certa SSc trial site

Malbork, Poland

Location

Certa SSc trial site

Warsaw, Poland

Location

Certa SSc trial site

Barcelona, Spain

Location

Certa SSc trial site

Kyiv, Ukraine

Location

Certa SSc trial site

Poltava, Ukraine

Location

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse

Interventions

FT011

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Prof Darren Kelly, CEO
• Organization: Certa Therapeutics Pty Ltd

dkelly@certatherapeutics.com

+61 3 9657 0700

Study Officials

• Darren Kelly, PhD

  Certa Therapeutics Pty Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 1, 2020
• Study Start: July 19, 2021
• Primary Completion: October 12, 2022
• Study Completion: November 16, 2022
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); NL (1); PL (4); UA (2); ES (1)