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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04166552
Registration number
NCT04166552
Ethics application status
Date submitted
6/11/2019
Date registered
18/11/2019
Date last updated
21/09/2023
Titles & IDs
Public title
Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis
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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
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Secondary ID [1]
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EHP-101-SS01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Cutaneous Systemic Sclerosis
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence and severity of Treatment Emergent Adverse Events
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Assessment method [1]
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This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
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Timepoint [1]
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Day 113
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Secondary outcome [1]
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Treatment effect of EHP-101 compared to placebo as measured by the American College of Rheumatology composite response index in diffuse cutaneous Systemic Sclerosis
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Assessment method [1]
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The ACR CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in modified Rodnan Skin Score (mRSS), Forced Vital Capacity (FVC) % predicted, physician and patient global assessments, and Scleroderma Health Assessment Questionnaire Disability Index (S-HAQ-DI). The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). Subjects are not considered improved (ACR CRISS score = 0) if they develop new: 1) renal crisis; 2) decline in FVC% predicted by 15% (relative) from baseline and confirmed after 1 month; or 3) left ventricular failure (systolic ejection fraction < 45%); or 4) new pulmonary artery hypertension on right heart catheterization requiring treatment.
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Timepoint [1]
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Day 85 and Day 113
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Secondary outcome [2]
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Treatment effect of EHP-101 compared to placebo in modified Rodnan Skin Score
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Assessment method [2]
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The mRSS consists of an 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.
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Timepoint [2]
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Day 85 and Day 113
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Secondary outcome [3]
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Treatment effect of EHP-101 compared to placebo in forced vital capacity percent predicted
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Assessment method [3]
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Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness . FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%
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Timepoint [3]
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Day 85 and Day 113
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Secondary outcome [4]
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Treatment effect of EHP-101 compared to placebo in physician global assessment score
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Assessment method [4]
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The Physician Global Assessment of disease activity will be performed using a segmented numerical version of the visual analogue scale in which the physician selects a whole number (0-10 integers) that best reflects the overall disease activity. The numerical rating score is anchored by 2 verbal descriptors, one of "no disease activity" (score of 0) and one of "worse imaginable disease activity" (score of 10), with numbers 1-9 spaced equidistance in between. The physician will select an integer to describe disease activity. The recall period is one week.
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Timepoint [4]
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Day 85 and Day 113
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Secondary outcome [5]
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Treatment effect of EHP-101 compared to placebo in patient global assessments score
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Assessment method [5]
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The Patient Global Assessment will be performed with a segmented numerical version of the visual analogue scale in which the subject selects a whole number (0-10 integers) that best reflects the overall disease activity. The numerical rating score is anchored by two verbal descriptors, one of "no disease activity" (score of 0) and one of "worse imaginable disease activity" (score of 10), with numbers 1-9 spaced equidistance in between. The subject will select an integer to describe disease activity. The recall period is one week.
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Timepoint [5]
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Day 85 and Day 113
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Secondary outcome [6]
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Treatment effect of EHP-101 compared to placebo in Scleroderma Health Assessment Questionnaire - Disability Index
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Assessment method [6]
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S-HAQ-DI includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are two or three questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The eight scores of the eight sections are summed and divided by 8. If one section is not completed by a subject, the summed score is divided by 7. As such, maximum scores can vary with a min of 0. The result is the DI, the disability index or functional disability index. The recall period is one week.
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Timepoint [6]
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Day 85 and Day 113
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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.
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Minimum age
18
Years
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Maximum age
74
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Suspended
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2024
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
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Footscray Hospital - Footscray
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Recruitment hospital [4]
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Griffith University - Gold Coast
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Recruitment hospital [5]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [6]
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Westmead Hospital - Sydney
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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3011 - Footscray
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Recruitment postcode(s) [4]
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9726 - Gold Coast
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Recruitment postcode(s) [5]
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6150 - Murdoch
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Recruitment postcode(s) [6]
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2145 - Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Connecticut
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Country [4]
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United States of America
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State/province [4]
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Florida
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Country [5]
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United States of America
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State/province [5]
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Illinois
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Country [6]
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United States of America
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State/province [6]
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Minnesota
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Country [7]
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United States of America
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State/province [7]
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New Jersey
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Country [8]
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United States of America
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State/province [8]
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Ohio
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Country [9]
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New Zealand
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State/province [9]
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Wellington
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Puerto Rico
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State/province [10]
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Caguas
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Country [11]
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Puerto Rico
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State/province [11]
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San Juan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Emerald Health Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and
preliminary efficacy of EHP-101 in adult subjects with diffuse cutaneous Systemic Sclerosis
(dcSSc).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04166552
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04166552
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