The purpose of this study is to assess short-term and the long-term safety and efficacy of oral ZPL389 (30 mg once daily (o.d.) and 50 mg o.d.) when used concomitantly or intermittently with topical corticosteroid (TCS) and/or topical calcineurin…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the short-term and long-term safety of 30 mg o.d. and 50 mg o.d.
ZPL389 with concomitant or intermittent use of TCS and/or TCI up to total of 32
weeks and 116 weeks of treatment.
Secondary outcome
* To evaluate the efficacy of 30 mg o.d. and 50 mg o.d. ZPL389 with concomitant
or intermittent use of TCS and/or TCI as assessed by investigator's global
assessment (IGA) response over time.
* To evaluate the efficacy of 30 mg o.d. and 50 mg o.d. ZPL389 with concomitant
or intermittent use of TCS and/or TCI as assessed by eczema area and severity
index (EASI) over time.
Background summary
Atopic dermatitis is also called atopic eczema. It is a form of skin
inflammation. Symptoms include itching, redness and swelling of the skin. The
skin spots can be moist and may have scabs on it. Two to ten percent of the
adults and up to 20 percent of the children have AD, of which about 70% and 16%
are moderate to severe. The usual treatment of AD consists of moisturizing
cream, anti-inflammatory ointment (eg with corticosteroids), light therapy and
anti-inflammatory pills ". Unfortunately, some of the patients have
insufficient benefit from these existing treatments or can not tolerate them
well. There is therefore a need for new medicines.
ZPL389 is a substance that attaches to a body protein called the histamine 4
receptor (H4R). Histamine is made by the body when it comes into contact with a
substance for which it is hypersensitive. Histamine attaches itself to the H4R
and therefore causes skin symptoms such as itching. ZPL389 is so firmly
attached to the H4R that histamine can no longer attach itself to it. We
therefore expect that ZPL389 can counteract the symptoms of atopic dermatitis.
Study objective
The purpose of this study is to assess short-term and the long-term safety and
efficacy of oral ZPL389 (30 mg once daily (o.d.) and 50 mg o.d.) when used
concomitantly or intermittently with topical corticosteroid (TCS) and/or
topical calcineurin inhibitors (TCI) (according to a standardized regimen,
depending on atopic dermatitis lesion severity, in line with common/ real world
practice) for up to approximately 2 years in adult patients with atopic
dermatitis who previously completed 16 weeks of treatment in the core study
(CZPL389A2203).
Study design
This 2-year study is a randomized, double blind, parallel group, 2-arm study in
up to approximately 202 to 230 subjects with atopic dermatitis (AD) who have
completed 16 weeks of treatment in the CZPL389A2203 (core study). In this
extension study, subjects who have been receiving ZPL389 30 mg o.d. or 50 mg
o.d. doses in the core study, will continue to receive the same doses. Subjects
who were receiving ZPL389 3 mg, 10 mg or placebo in the core study will be
randomized into 30 mg o.d. or 50 mg o.d. ZPL389 in a 1:1 ratio. All subjects
will receive concomitant or intermittent TCS and/or TCI along with ZPL389.
Subjects, after completing 100 weeks of treatment during extension study (i.e.
up to Week 116 starting from Week 16 of the core study), will enter a
treatment-free follow-up period for 4 weeks.
Intervention
ZPL389 will be administered orally in capsules in one of the two following
treatment arms:
ZPL389 30 mg o.d. + TCS and/or TCI
ZPL389 50 mg o.d. + TCS and/or TCI
Study burden and risks
During the total course of the trial the following assessments will be
done/requested:
- Physical examination: 12x
- ECG: 12x
- Vital signs: 12x
- Blood test (10 ml): 12x
- Pregnancy test (if applicable) 12x
- Urine test: 13x
- Diary completion: daily
- Complete questionnaires: 6x
Haaksbergweg 16
Amsterdam 1101 BX
NL
Haaksbergweg 16
Amsterdam 1101 BX
NL
Listed location countries
Age
Inclusion criteria
* Signed informed consent must be obtained before any assessment is performed.
* Female and male subjects with atopic dermatitis who have participated in and
completed 16 weeks of study treatment in CZPL389A2203 study.
* Willing and able to comply with scheduled visits, treatment plan, laboratory
tests, diary
completion and other study procedures.
Exclusion criteria
* Inability to use TCS and/or TCI concomitantly or intermittently due to
history of important side effects of topical medication (e.g. intolerance to
treatment, hypersensitivity reactions, significant skin atrophy, systemic
effects), as assessed by the investigator or subject*s treating physician.
* Subjects who met any study and/or treatment discontinuation criteria during
the
CZPL389A2203 study.
* Any active skin disease that, in the opinion of the investigator, would
confound the diagnosis
or evaluation of AD disease activity (e.g. Netherton Syndrome, Cutaneous T-Cell
Lymphoma, extensive contact dermatitis, chronic actinic dermatitis).
* Subjects taking medications prohibited by the protocol.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential (WOCBP), defined as all women
physiologically capable of becoming pregnant, unless they use required methods
of contraception during dosing and for 4 weeks after stopping of
investigational medication.
* Sexually active males unless they use a condom during intercourse while
taking drug and for 4 weeks after stopping investigational medication and
should not father a child in this period. A condom is required to be used also
by vasectomized men in order to prevent delivery of the drug via seminal fluid.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR201800059515-NL |
| ClinicalTrials.gov | NCT03948334 |
| CCMO | NL69078.078.19 |