Plague-Type Psoriasis

The primary objective of this study is:  To gain evidence regarding the efficacy (activity) of two different strengths of KX01 ointment in the treatment of plaque-type psoriasis. The secondary objective of this study is:  To evaluate the safety and tolerability of two different strengths of KX01 ointment in patients with plaque-type psoriasis.

KX01 Ointment

KX01

Ointment

0.1 mg/g、1.0 mg/g、10 mg/g

Primary Endpoint
Efficacy (activity)
 Change in target area score (TAS) between baseline and End of Treatment (EOT)

Secondary Endpoints
Safety and Tolerability
 Adverse events
 Laboratory assessments (hematology, clinical chemistry and urinalysis)
 Vital signs
 12-lead electrocardiogram (ECG)
 Physical examination
 Serum KX01 concentrations
 Physician’s Global Assessment of the target lesions
 Local tolerability score
 Percentage of disease relapse

Inclusion Criteria
Patients who meet the following criteria will be considered eligible to participate in the clinical
study:
1. Male and female patients with plaque-type psoriasis, 20 years and older.
2. Patient had a confirmed diagnosis of chronic plaque-type psoriasis (without recent
documented flare within 30 days prior to screening) for at least six months.
3. Patient has at least two psoriatic plaques, of at least 16 cm² in size (no upper limit). Each
lesion should have comparable size, similar severity and not be contiguous. These lesions
would serve as target lesions (assessed at screening and Day 1). The lesions should be in
an area sufficient for the application of the IMP and meet the following criteria:
 Located on the trunk and/or the extremities, e.g. lesions located on the head, palms or
soles of the feet. Intertriginous or genitoanal areas are not suitable.
 Plaques should be comparable and should have similar target area score (TAS) (no
more than 1 point difference at baseline)
 No evidence of atrophy in the areas selected for treatment.
4. Medical history, vital signs, physical examination, standard 12-lead ECG and laboratory
investigations must be clinically insignificant or within laboratory reference ranges for the
relevant laboratory tests, unless the investigator considers the deviation for out of range
values to be irrelevant for the purpose of the study.
5. No other disorders that, in the investigator's opinion, could prevent the patient from safely
participating in this study or interfere with the evaluation of the patient's psoriasis.
6. Patient is able to discontinue the use of any systemic medication or therapy (e.g. oral or
injectable psoriasis medications, psoralen plus long-wave ultraviolet [PUVA] therapy,
herbal remedies, etc.) for psoriasis.
7. For females, either of the following conditions are to be met:
 Not of childbearing potential:
- Surgically sterilized, undergone a hysterectomy, amenorrhea for ≥ 12 months
and considered post-menopausal. Post-menopausal status will be confirmed by
evaluation of follicle stimulating hormone (FSH) (FSH > 40 mIU/mL and
estradiol < 40 pg/mL [<147 pmol/L] are confirmatory).
 Of childbearing potential:
- Negative serum pregnancy test at screening and not lactating. If this test is
positive, the patient will be excluded from the study. In the rare circumstance
that a pregnancy is discovered after the patient received IMP, every attempt
must be made to follow her to term.
- Either abstaining from sexual activity (if this is the usual lifestyle of the patient)
or must agree to use an accepted method of contraception, and agree to continue
with the same method throughout the study.
- Examples of reliable methods of contraception include oral contraceptive pill
(documented that the dose has been stable for at least one month before the first
intake of IMP), injectable or implantable contraceptives, intrauterine device,
and barrier methods combined with an additional contraceptive method.
- Other methods, if considered by the investigator as reliable, will be accepted.
8. Male patients with partners of childbearing potential must be willing to use contraception
during the study and three months after end of treatment and must not donate sperm for the
duration of the study and for 3 months thereafter.
9. Patient must be able to provide written informed consent prior to the initiation of any study
related procedures and able to comply with all the requirements of the study, including
study visits and restrictions.

Exclusion Criteria
Patients who meet one or more of the following criteria will not be considered eligible to
participate in the clinical study:
1. History of hypersensitivity to the IMP or to medicinal products with similar chemical
structures.
2. Presence of a skin disorder other than psoriasis in the target areas to be evaluated, including
forms of inflammatory or non-inflammatory skin disorders that might interfere with
determining efficacy or tolerability of the IMP.
3. Severe forms of psoriasis or forms of psoriasis other than plaque psoriasis.
4. All systemic psoriasis medications, including PUVA radiation treatments or other systemic
immunosuppressive medication, are not allowed within five half-lives or 1 month
(whichever is longer) prior to the first administration of the IMP, i.e. methotrexate and
cyclosporin within one month prior to the first administration of the IMP and PUVA within
one month prior to the first administration of the IMP.
5. The use of topical therapies for psoriasis, including ultraviolet light B, on the target lesions
to be studied within two weeks prior to the first administration of the IMP. The use of
topical calcipotriol at a dose up to 30 g per week or ultraviolet light B for psoriasis on nontreatment lesions is permitted during the study.
6. Previous treatment with anti-TNF/IL-12/IL-23 or any other monoclonal antibodies within
three months prior to the first administration of the IMP.
7. Presence or history of any clinically significant acute or chronic disease which could
interfere with the patient’s participation or study outcome and at discretion of the clinical
investigator.
8. Patient with drug-induced psoriasis and is unable to discontinue the causal agent(s).
9. Patient using prescription or non-prescription systemic drugs (e.g. vitamins and dietary,
herbal supplements, Paracetamol, aspirin or non-steroidal anti-inflammatory drugs
(NSAIDs)) that might have an effect on psoriasis and is unable to maintain the stable dose
or discontinue the dose during the study period.
10. Participation in another study with an experimental drug, where the last administration of
the previous IMP was within one month (or within five elimination half-lives for chemical
entities or two elimination half-lives for antibodies or insulin, whichever is longer) before
administration of IMP in this study, at the discretion of the investigator.
11. A positive serum pregnancy test (beta human chorionic gonadotropin [-HCG]) or lactation.
12. Vulnerable patients, e.g. persons in detention.