A Randomised, Double-blind, Placebo-controlled, Phase 2 Study to Assessthe Efficacy and Safety of Orally Administered DS107 in a once daily doseof 2g in Haemodialysis Patients with Moderate to Severe Uremic Pruritus

Phase 1

• Conditions: Moderate to Severe Uremic Pruritus; MedDRA version: 20.0Level: LLTClassification code 10060884Term: Uremic pruritusSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-004098-15-LV
• Lead Sponsor: DS Biopharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-23
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Male or female patients who are aged 18 years and older on the day of
signing the informed consent form (ICF).
2. Patients who are on stable haemodialysis 3 times a week for at least 3
months prior to screening with a urine production of less than 300 ml
per day.
3. Patients with continued (uncontrolled) pruritus despite standard of
care in the institution.
4. Patients with severe pruritus, as determined by qualifying mean worst
NRS score in a day of =5 (on 11 point NRS) at the screening visit.
5. Female patients and male patients with female partners of child
bearing potential must use adequate contraception or have a sterilised
partner for the duration of the study. Adequate contraception is defined
as: systemic hormonal contraceptives, intrauterine device or agree to
sexual abstinence. Hormonal contraceptives must be on a stable dose for
at least one month before baseline.
6. Patients whose pre-study clinical laboratory findings do not interfere
with their participation in the study, in the opinion of the Investigator.
7. Patients who are able to communicate well with the Investigator, to
understand and comply with the requirements of the study, and
understand and sign the written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Patients who are known to be non-compliant with dialysis treatment
(i.e., has missed more than 2 dialysis sessions in the past 2 months
because of non-compliance).
2. Patients who are anticipated to receive a kidney transplant during the
study.
3. Patients on peritoneal dialysis.
4. Patients with substantial residual renal output (>300 ml per day).
5. Patients with pruritus only during the dialysis session (by patient
report).
6. Patients with pruritus probably or definitely attributed to a cause
other than end stage renal disease or its complications (e.g., patients
with concomitant pruritic dermatological disease or cholestatic liver
disease will be excluded).
7. Patients with a serum alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) greater than 2.5 times the reference upper limit
of normal (ULN), or total bilirubin greater than 2 times ULN at screening.
8. Patients with a history of clinically significant drug or alcohol abuse in
the opinion of the investigator in the last year prior to Baseline (Day 0).
9. Patients using any topical agents with potential antipruritic activity,
excluding emollients, during the 2 weeks before the baseline visit.
10. Patients with systemic antipruritic treatment during the 2 weeks
before the baseline visit. Second and third generation oral
antihistamines are allowed if the patient is on stable dose of
antihistamine and this dose is not changed during the study period. First
generation oral antihistamines are disallowed.
11. Patients on immuno-suppressant treatment such as Cyclosporine A
(CsA), Methotrexate, Glucocorticoid steroids and similar compounds.
12. Patients who have received ultraviolet B treatment in the 4 weeks
prior to the start of Screening or anticipated to receive such treatment
during the study.
13. Patients who have participated in any other clinical study with an
investigational medicinal product (IMP) within 3 months before the first
day of administration of study treatment.
14. Patients who are pregnant, planning pregnancy, breastfeeding
and/or are unwilling to use adequate contraception (as specified in
inclusion criterion 5) during the trial.
15. Patients, in the opinion of the Investigator, not suitable to
participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Week 12;Main Objective: To compare the efficacy of orally administered DS107 versus placebo, in<br>the treatment of adult haemodialysis patients with moderate to severe<br>Uremic Pruritus (UP).;Secondary Objective: To assess the safety of orally administered DS107 versus placebo, in<br>adult haemodialysis patients with UP.;Primary end point(s): Change from baseline in worst-itching over the last 24 hours on the 11-<br>point Numerical Rating Scale (NRS) in DS107 treated population<br>compared to placebo at Week 12.