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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04166552




Registration number
NCT04166552
Ethics application status
Date submitted
6/11/2019
Date registered
18/11/2019

Titles & IDs
Public title
Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis
Scientific title
A Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients With Diffuse Cutaneous Systemic Sclerosis
Secondary ID [1] 0 0
EHP-101-SS01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Cutaneous Systemic Sclerosis 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 - Patients will be randomized to receive EHP-101 or Placebo
Treatment: Drugs - Patients will be randomized to receive EHP-101 or Placebo

Experimental: EHP-101 low dose once a day -

Experimental: EHP-101 low dose twice a day -

Experimental: EHP-101 high dose once a day -

Experimental: EHP-101 high dose twice a day -


Treatment: Drugs: Patients will be randomized to receive EHP-101 or Placebo
EHP-101 or placebo will be taken once a day

Treatment: Drugs: Patients will be randomized to receive EHP-101 or Placebo
EHP-101 or placebo will be taken twice a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of Treatment Emergent Adverse Events
Timepoint [1] 0 0
Day 113
Secondary outcome [1] 0 0
Treatment effect of EHP-101 compared to placebo as measured by the American College of Rheumatology composite response index in diffuse cutaneous Systemic Sclerosis
Timepoint [1] 0 0
Day 85 and Day 113
Secondary outcome [2] 0 0
Treatment effect of EHP-101 compared to placebo in modified Rodnan Skin Score
Timepoint [2] 0 0
Day 85 and Day 113
Secondary outcome [3] 0 0
Treatment effect of EHP-101 compared to placebo in forced vital capacity percent predicted
Timepoint [3] 0 0
Day 85 and Day 113
Secondary outcome [4] 0 0
Treatment effect of EHP-101 compared to placebo in physician global assessment score
Timepoint [4] 0 0
Day 85 and Day 113
Secondary outcome [5] 0 0
Treatment effect of EHP-101 compared to placebo in patient global assessments score
Timepoint [5] 0 0
Day 85 and Day 113
Secondary outcome [6] 0 0
Treatment effect of EHP-101 compared to placebo in Scleroderma Health Assessment Questionnaire - Disability Index
Timepoint [6] 0 0
Day 85 and Day 113

Eligibility
Key inclusion criteria
* Patients male and female =18 years and =74 years at the time of consent;
* American College of Rheumatology/ European League Against Rheumatism 2013 Criteria for SSc; dcSSc (skin thickening on upper arms, upper legs, or trunk);
* Documented SSc for up to 6 years from the first non-Raynaud's phenomenon with a total mRSS of =15;
* No new or increased doses of immunosuppressants medications within 3 months prior to Screening;
* Effective method of contraception for participants and their partners.
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Severe or unstable Systemic Sclerosis (SSc) or SSc with end-stage organ failure;
* Patient with FVC <60%;
* History of clinically significant medical condition or concurrent medical therapies that would exclude the patient, preclude participation in the clinical trial, influence response to study product, or interfere with study assessments;
* History of gastrointestinal dysmotility requiring total parenteral nutrition or hospitalization within 6 months before Visit 1;
* Any one of the following values for laboratory tests at screening:

* Haemoglobin <9 g/dL;
* Neutrophils <1.0 x 10^9/L;
* Platelets <75 x 10^9/L;
* Estimated creatinine clearance <50 mL/min according to the Cockcroft-Gault equation;
* Serum transaminases >2.0 x upper normal limit;
* Total bilirubin =1.5 x upper limit of normal.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Footscray Hospital - Footscray
Recruitment hospital [4] 0 0
Griffith University - Gold Coast
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [6] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
9726 - Gold Coast
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
New Zealand
State/province [9] 0 0
Wellington
Country [10] 0 0
Puerto Rico
State/province [10] 0 0
Caguas
Country [11] 0 0
Puerto Rico
State/province [11] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Emerald Health Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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?

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/NCT04166552