Back to resultsKX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
KX01 0.01% (0.1 mg/g)
Placebo
KX01 0.1% (1.0 mg/g)
KX01 1% (10 mg/g) for 5 days
KX01 1% (10 mg/g) for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring KX01, Ointment, Psoriasis, Phase I, Clinical trial
Eligibility Criteria
Inclusion Criteria:
- Male and female patients with plaque-type psoriasis, 20 years and older.
- Patient has a confirmed diagnosis of chronic plaque-type psoriasis for at least six months. For stage 4, PGA should be ≧3 &≦5 at baseline.
- A single lesion of ≥ 16 square centimetre and ≤ 625 square centimetre in size for Stage 1 and 2, and ≥ 16 square centimetre and ≤ 100 square centimetre in size for Stage 3 and 4 are selected as the target lesion (assessed at screening and Day 1).
- Medical history, vital signs, physical examination, standard 12-lead ECG and laboratory investigations have to be clinically insignificant or within laboratory reference ranges for the relevant laboratory tests, unless the investigator consider the deviation for out of range values to be irrelevant for the purpose of the study.
- No other disorders that, in the investigator's opinion, will prevent the patient from safely participating in this study or interfere with the evaluation of the patient's psoriasis.
- Patient is able to discontinue the use of any systemic medication or therapy for psoriasis.
- For females, either of the following conditions will be met: 1. Not of childbearing potential: Surgically sterilized, undergone a hysterectomy, amenorrhea for ≥ 12 months and considered post-menopausal; 2. Of childbearing potential: Negative serum pregnancy test at screening and not lactating, Either abstaining from sexual activity, or have to agree to use an accepted method of contraception, and agree to continue with the same method throughout the study.
- Male patients with partners of childbearing potential have to be willing to use contraception during the study and three months after end of treatment and is not to donate sperm for the duration of the study and for 3 months thereafter.
- Patient have to 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.
Exclusion Criteria:
- History of hypersensitivity to the investigational medicinal product (IMP) or to medicinal products with similar chemical structures.
- 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.
- Severe forms of psoriasis or forms of psoriasis other than plaque psoriasis.
- All systemic psoriasis medications, including psoralens and ultraviolet A radiation treatments or other systemic immunosuppressive medication, are not allowed within five half-lives or 4 weeks (whichever is longer) prior to the first administration of the IMP.
- The use of topical therapies for psoriasis, including ultraviolet light B, on the target lesion to be studied within two weeks prior to the first administration of the IMP.
- Previous treatment with anti-tumor necrosis factor/interleukin (IL)-12/IL-23 or any other monoclonal antibodies within three months prior to the first administration of the IMP.
- 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.
- Patient with drug-induced psoriasis and is unable to discontinue the causal agent(s).
- 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.
- Participation in another study with an experimental drug, where the last administration of the previous IMP is within 4 weeks (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.
- A positive serum pregnancy test (beta human chorionic gonadotropin) or lactation.
- Vulnerable patients, e.g. persons in detention.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
KX01 0.01% in stage I
Placebo in stage 1
KX01 0.1% in stage 2
Placebo in stage 2
KX01 1% for 5 days in stage 3
KX01 1% for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles in stage 4
Arm Description
Six patients in the stage 1 will receive KX01 0.01% (0.1 mg/g) for 2 weeks, followed by 1-week wash-out, another 2-week treatment, and then 2-week follow-up.
Two patients in the stage 1 will receive placebo treatment for 2 weeks, followed by 1-week wash-out, another 2-week treatment, and then 2-week follow-up.
Six patients in the stage 2 will receive KX01 0.1% (1.0 mg/g) for 4 weeks, followed by 2-week follow-up.
Two patients in the stage 2 will receive placebo treatment for 4 weeks, followed by 2-week follow-up.
Six patients in stage 3 will receive 1% KX01 (10 mg/g) once daily for consecutive 5 days and then receive post-treatment follow-up on Day 6, 15 and 29.
Six patients in stage 4 will be treated with daily KX01 1% (10 mg/g) ointment for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles. And post-treatment follow-up visits will be conducted 14 days (Follow-up visit 1) and 28 days (Follow-up visit 2) after the end of cycle 4 treatment.
Outcomes
Primary Outcome Measures
Adverse event at Stage 1
Incidence of adverse event
Adverse event at Stage 2
Incidence of adverse event
Adverse event at Stage 3
Incidence of adverse event
Adverse event at Stage 4
Incidence of adverse event
Local tolerability score at Stage 1
4-point (0-3) rating scale; higher scores mean a worse outcome
Local tolerability score at Stage 2
4-point (0-3) rating scale; higher scores mean a worse outcome
Local tolerability score at Stage 3
4-point (0-3) rating scale; higher scores mean a worse outcome
Local tolerability score at Stage 4
4-point (0-3) rating scale; higher scores mean a worse outcome
Vital signs at Stage 1
Vital signs at Stage 2
Vital signs at Stage 3
Vital signs at Stage 4
12-lead ECG at Stage 1
12-lead ECG at Stage 2
12-lead ECG at Stage 3
12-lead ECG at Stage 4
Laboratory assessments at Stage 1
hematology, clinical chemistry and urinalysis
Laboratory assessments at Stage 2
hematology, clinical chemistry and urinalysis
Laboratory assessments at Stage 3
hematology, clinical chemistry and urinalysis
Laboratory assessments at Stage 4
hematology, clinical chemistry and urinalysis
Secondary Outcome Measures
Change between baseline and end of treatment in target area score (TAS) at Stage 1
Change between baseline and end of treatment in TAS that evaluates the target lesion's erythema (0-4), plaque elevation (0-4) and scaling (0-4) on a five-point scale for each item (higher scores mean a worse outcome)
Change between baseline and end of TAS at Stage 2
Change between baseline and end of treatment in TAS that evaluates the target lesion's erythema (0-4), plaque elevation (0-4) and scaling (0-4) on a five-point scale for each item
Change between baseline and end of TAS at Stage 3
Change between baseline and end of treatment in TAS that evaluates the target lesion's erythema (0-4), plaque elevation (0-4) and scaling (0-4) on a five-point scale for each item
Change between baseline and end of TAS at Stage 4
Change between baseline and end of treatment in TAS that evaluates the target lesion's erythema (0-4), plaque elevation (0-4) and scaling (0-4) on a five-point scale for each item
TAS 50 at Stage 1
≧50% reduction in TAS score from baseline at the end of treatment
TAS 50 at Stage 2
≧50% reduction in TAS score from baseline at the end of treatment
TAS 50 at Stage 3
≧50% reduction in TAS score from baseline at the end of treatment
TAS 50 at Stage 4
≧50% reduction in TAS score from baseline at the end of treatment
Physician global assessment (PGA) score of the target lesion at the end of treatment of Stage 1
Achieving a score of "clear" (grade 0) or "almost clear" (grade 1) and at least 2 grade improvement from the baseline score in a 7-point score (0-6, higher scores mean a worse outcome).
PGA score of the target lesion at the end of treatment of Stage 2
Achieving a score of "clear" (grade 0) or "almost clear" (grade 1) and at least 2 grade improvement from the baseline score in a 7-point score
PGA score of the target lesion at the end of treatment of Stage 3
Achieving a score of "clear" (grade 0) or "almost clear" (grade 1) and at least 2 grade improvement from the baseline score in a 7-point score
PGA score of the target lesion at the end of treatment of Stage 4
Achieving a score of "clear" (grade 0) or "almost clear" (grade 1) and at least 2 grade improvement from the baseline score in a 7-point score
Disease relapse at Stage 2
Relapse is the loss of more than 50% of TAS improvement from baseline in patients who achieve a clinically meaningful response. Clinical meaningful response is defined as a reduction of ≥50% in TAS from baseline during the treatment.
Disease relapse at Stage 3
Relapse is the loss of more than 50% of TAS improvement from baseline in patients who achieve a clinically meaningful response. Clinical meaningful response is defined as a reduction of ≥50% in TAS from baseline during the treatment.
Disease relapse at Stage 4
Relapse is the loss of more than 50% of TAS improvement from baseline in patients who achieve a clinically meaningful response. Clinical meaningful response is defined as a reduction of ≥50% in TAS from baseline during the treatment.
Plasma KX01 concentrations (ng/ml) at Stage 1
Detection of plasma KX01 concentrations (ng/ml)
Plasma KX01 concentrations (ng/ml) at Stage 2
Detection of plasma KX01 concentrations (ng/ml)
Plasma KX01 concentrations (ng/ml) at Stage 3
Detection of plasma KX01 concentrations (ng/ml)
Plasma KX01 concentrations (ng/ml) at Stage 4
Detection of plasma KX01 concentrations (ng/ml)
Full Information
NCT ID
NCT05522816
First Posted
August 25, 2022
Last Updated
August 29, 2022
Sponsor
PharmaEssentia
Collaborators
Athenex, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05522816
Brief Title
KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis
Official Title
A Phase 1, Dose Escalation Trial to Evaluate the Safety, Tolerability and Activity of Topical Administrations of Three Different Strengths of KX01 Ointment in Patients With Plaque Type Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 27, 2015 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaEssentia
Collaborators
Athenex, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase I dose escalation study to assess the safety, tolerability and activity of three different strengths of topical KX01 in the treatment of patients with plaque-type psoriasis.
Detailed Description
This is a Phase I dose escalation study to assess the safety, tolerability and activity of three different strengths of topical KX01 in the treatment of patients with plaque-type psoriasis. The study will be performed in four stages as below.
Stage I: 6 patients (KX01 0.01% [0.1 mg/g]) + 2 patients (placebo); Stage II: 6 patients (KX01 0.1% [1.0 mg/g] + 2 patients (placebo); Stage III: 6 patients (KX01 1% [10 mg/g]) for 5 days; Stage IV: 6 patients (KX01 1% [10 mg/g]), duration escalation for up to 4 cycles.
If there's no major safety concern in the previous stage with an unanimous consent by the sponsor and the principle investigator, the study proceeded to the next stage.
The primary objective is to evaluate the safety and tolerability of three different strengths of KX01 ointment in patients with plaque-type psoriasis. The secondary objective is to gain evidence regarding the activity of three different strengths of KX01 ointment in patients with plaque-type psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
KX01, Ointment, Psoriasis, Phase I, Clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
The study will be sequentially performed in four stages, including stage 1 to stage 4. If no major safety concern was identified in the previous stage, as well as an unanimous consent by the sponsor and the principle investigator(s), the study will proceed to the next stage.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization and masking will be conducted in stage 1 and stage 2. Eight patients are randomized to received KX01 or placebo control in a ratio of 3:1 (KX01 versus placebo) in these 2 stages. Double blind are applied to the assignment of KX01 and placebo.
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KX01 0.01% in stage I
Arm Type
Experimental
Arm Description
Six patients in the stage 1 will receive KX01 0.01% (0.1 mg/g) for 2 weeks, followed by 1-week wash-out, another 2-week treatment, and then 2-week follow-up.
Arm Title
Placebo in stage 1
Arm Type
Placebo Comparator
Arm Description
Two patients in the stage 1 will receive placebo treatment for 2 weeks, followed by 1-week wash-out, another 2-week treatment, and then 2-week follow-up.
Arm Title
KX01 0.1% in stage 2
Arm Type
Experimental
Arm Description
Six patients in the stage 2 will receive KX01 0.1% (1.0 mg/g) for 4 weeks, followed by 2-week follow-up.
Arm Title
Placebo in stage 2
Arm Type
Placebo Comparator
Arm Description
Two patients in the stage 2 will receive placebo treatment for 4 weeks, followed by 2-week follow-up.
Arm Title
KX01 1% for 5 days in stage 3
Arm Type
Experimental
Arm Description
Six patients in stage 3 will receive 1% KX01 (10 mg/g) once daily for consecutive 5 days and then receive post-treatment follow-up on Day 6, 15 and 29.
Arm Title
KX01 1% for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles in stage 4
Arm Type
Experimental
Arm Description
Six patients in stage 4 will be treated with daily KX01 1% (10 mg/g) ointment for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles. And post-treatment follow-up visits will be conducted 14 days (Follow-up visit 1) and 28 days (Follow-up visit 2) after the end of cycle 4 treatment.
Intervention Type
Drug
Intervention Name(s)
KX01 0.01% (0.1 mg/g)
Intervention Description
Stage 1: 6 patients (KX01 0.01% [0.1 mg/g])
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
KX01 0.1% (1.0 mg/g)
Intervention Description
Stage 2: 6 patients (KX01 0.1% [1.0 mg/g])
Intervention Type
Drug
Intervention Name(s)
KX01 1% (10 mg/g) for 5 days
Intervention Description
Stage 3: 6 patients (KX01 1% [10 mg/g]) for 5 days
Intervention Type
Drug
Intervention Name(s)
KX01 1% (10 mg/g) for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles
Intervention Description
Stage 4: 6 patients (KX01 1% [10 mg/g])for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles
Primary Outcome Measure Information:
Title
Adverse event at Stage 1
Description
Incidence of adverse event
Time Frame
Day 50
Title
Adverse event at Stage 2
Description
Incidence of adverse event
Time Frame
Day 43
Title
Adverse event at Stage 3
Description
Incidence of adverse event
Time Frame
Day 29
Title
Adverse event at Stage 4
Description
Incidence of adverse event
Time Frame
28 days after the end of cycle 4 treatment (each cycle is 7 days)
Title
Local tolerability score at Stage 1
Description
4-point (0-3) rating scale; higher scores mean a worse outcome
Time Frame
Day 50
Title
Local tolerability score at Stage 2
Description
4-point (0-3) rating scale; higher scores mean a worse outcome
Time Frame
Day 43
Title
Local tolerability score at Stage 3
Description
4-point (0-3) rating scale; higher scores mean a worse outcome
Time Frame
Day 29
Title
Local tolerability score at Stage 4
Description
4-point (0-3) rating scale; higher scores mean a worse outcome
Time Frame
28 days after the end of cycle 4 treatment (each cycle is 7 days)
Title
Vital signs at Stage 1
Time Frame
Day 50
Title
Vital signs at Stage 2
Time Frame
Day 43
Title
Vital signs at Stage 3
Time Frame
Day 29
Title
Vital signs at Stage 4
Time Frame
28 days after the end of cycle 4 treatment (each cycle is 7 days)
Title
12-lead ECG at Stage 1
Time Frame
Day 36
Title
12-lead ECG at Stage 2
Time Frame
Day 29
Title
12-lead ECG at Stage 3
Time Frame
Day 29
Title
12-lead ECG at Stage 4
Time Frame
28 days after the end of cycle 4 treatment (each cycle is 7 days)
Title
Laboratory assessments at Stage 1
Description
hematology, clinical chemistry and urinalysis
Time Frame
Day 36
Title
Laboratory assessments at Stage 2
Description
hematology, clinical chemistry and urinalysis
Time Frame
Day 29
Title
Laboratory assessments at Stage 3
Description
hematology, clinical chemistry and urinalysis
Time Frame
Day 29
Title
Laboratory assessments at Stage 4
Description
hematology, clinical chemistry and urinalysis
Time Frame
28 days after the end of cycle 4 treatment (each cycle is 7 days)
Secondary Outcome Measure Information:
Title
Change between baseline and end of treatment in target area score (TAS) at Stage 1
Description
Change between baseline and end of treatment in TAS that evaluates the target lesion's erythema (0-4), plaque elevation (0-4) and scaling (0-4) on a five-point scale for each item (higher scores mean a worse outcome)
Time Frame
Stage 1: Up to Day 36
Title
Change between baseline and end of TAS at Stage 2
Description
Change between baseline and end of treatment in TAS that evaluates the target lesion's erythema (0-4), plaque elevation (0-4) and scaling (0-4) on a five-point scale for each item
Time Frame
Up to Day 29
Title
Change between baseline and end of TAS at Stage 3
Description
Change between baseline and end of treatment in TAS that evaluates the target lesion's erythema (0-4), plaque elevation (0-4) and scaling (0-4) on a five-point scale for each item
Time Frame
Up to Day 6
Title
Change between baseline and end of TAS at Stage 4
Description
Change between baseline and end of treatment in TAS that evaluates the target lesion's erythema (0-4), plaque elevation (0-4) and scaling (0-4) on a five-point scale for each item
Time Frame
Up to the end of cycle 4 treatment (each cycle is 7 days)
Title
TAS 50 at Stage 1
Description
≧50% reduction in TAS score from baseline at the end of treatment
Time Frame
Up to Day 36
Title
TAS 50 at Stage 2
Description
≧50% reduction in TAS score from baseline at the end of treatment
Time Frame
Up to Day 29
Title
TAS 50 at Stage 3
Description
≧50% reduction in TAS score from baseline at the end of treatment
Time Frame
Up to Day 6
Title
TAS 50 at Stage 4
Description
≧50% reduction in TAS score from baseline at the end of treatment
Time Frame
Up to the end of cycle 4 treatment (each cycle is 7 days)
Title
Physician global assessment (PGA) score of the target lesion at the end of treatment of Stage 1
Description
Achieving a score of "clear" (grade 0) or "almost clear" (grade 1) and at least 2 grade improvement from the baseline score in a 7-point score (0-6, higher scores mean a worse outcome).
Time Frame
Up to Day 36
Title
PGA score of the target lesion at the end of treatment of Stage 2
Description
Achieving a score of "clear" (grade 0) or "almost clear" (grade 1) and at least 2 grade improvement from the baseline score in a 7-point score
Time Frame
Up to Day 29
Title
PGA score of the target lesion at the end of treatment of Stage 3
Description
Achieving a score of "clear" (grade 0) or "almost clear" (grade 1) and at least 2 grade improvement from the baseline score in a 7-point score
Time Frame
Up to Day 6
Title
PGA score of the target lesion at the end of treatment of Stage 4
Description
Achieving a score of "clear" (grade 0) or "almost clear" (grade 1) and at least 2 grade improvement from the baseline score in a 7-point score
Time Frame
Up to the end of cycle 4 treatment (each cycle is 7 days)
Title
Disease relapse at Stage 2
Description
Relapse is the loss of more than 50% of TAS improvement from baseline in patients who achieve a clinically meaningful response. Clinical meaningful response is defined as a reduction of ≥50% in TAS from baseline during the treatment.
Time Frame
Day 43
Title
Disease relapse at Stage 3
Description
Relapse is the loss of more than 50% of TAS improvement from baseline in patients who achieve a clinically meaningful response. Clinical meaningful response is defined as a reduction of ≥50% in TAS from baseline during the treatment.
Time Frame
Day 15 and Day 29
Title
Disease relapse at Stage 4
Description
Relapse is the loss of more than 50% of TAS improvement from baseline in patients who achieve a clinically meaningful response. Clinical meaningful response is defined as a reduction of ≥50% in TAS from baseline during the treatment.
Time Frame
14 days after cycle 4 treatment and 28 days after cycle 4 treatment (each cycle is 7 days)
Title
Plasma KX01 concentrations (ng/ml) at Stage 1
Description
Detection of plasma KX01 concentrations (ng/ml)
Time Frame
Up to Day 36
Title
Plasma KX01 concentrations (ng/ml) at Stage 2
Description
Detection of plasma KX01 concentrations (ng/ml)
Time Frame
Up to Day 29
Title
Plasma KX01 concentrations (ng/ml) at Stage 3
Description
Detection of plasma KX01 concentrations (ng/ml)
Time Frame
Up to Day 15
Title
Plasma KX01 concentrations (ng/ml) at Stage 4
Description
Detection of plasma KX01 concentrations (ng/ml)
Time Frame
14 days after cycle 4 treatment (each cycle is 7 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients with plaque-type psoriasis, 20 years and older.
Patient has a confirmed diagnosis of chronic plaque-type psoriasis for at least six months. For stage 4, PGA should be ≧3 &≦5 at baseline.
A single lesion of ≥ 16 square centimetre and ≤ 625 square centimetre in size for Stage 1 and 2, and ≥ 16 square centimetre and ≤ 100 square centimetre in size for Stage 3 and 4 are selected as the target lesion (assessed at screening and Day 1).
Medical history, vital signs, physical examination, standard 12-lead ECG and laboratory investigations have to be clinically insignificant or within laboratory reference ranges for the relevant laboratory tests, unless the investigator consider the deviation for out of range values to be irrelevant for the purpose of the study.
No other disorders that, in the investigator's opinion, will prevent the patient from safely participating in this study or interfere with the evaluation of the patient's psoriasis.
Patient is able to discontinue the use of any systemic medication or therapy for psoriasis.
For females, either of the following conditions will be met: 1. Not of childbearing potential: Surgically sterilized, undergone a hysterectomy, amenorrhea for ≥ 12 months and considered post-menopausal; 2. Of childbearing potential: Negative serum pregnancy test at screening and not lactating, Either abstaining from sexual activity, or have to agree to use an accepted method of contraception, and agree to continue with the same method throughout the study.
Male patients with partners of childbearing potential have to be willing to use contraception during the study and three months after end of treatment and is not to donate sperm for the duration of the study and for 3 months thereafter.
Patient have to 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.
Exclusion Criteria:
History of hypersensitivity to the investigational medicinal product (IMP) or to medicinal products with similar chemical structures.
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.
Severe forms of psoriasis or forms of psoriasis other than plaque psoriasis.
All systemic psoriasis medications, including psoralens and ultraviolet A radiation treatments or other systemic immunosuppressive medication, are not allowed within five half-lives or 4 weeks (whichever is longer) prior to the first administration of the IMP.
The use of topical therapies for psoriasis, including ultraviolet light B, on the target lesion to be studied within two weeks prior to the first administration of the IMP.
Previous treatment with anti-tumor necrosis factor/interleukin (IL)-12/IL-23 or any other monoclonal antibodies within three months prior to the first administration of the IMP.
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.
Patient with drug-induced psoriasis and is unable to discontinue the causal agent(s).
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.
Participation in another study with an experimental drug, where the last administration of the previous IMP is within 4 weeks (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.
A positive serum pregnancy test (beta human chorionic gonadotropin) or lactation.
Vulnerable patients, e.g. persons in detention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Bon Hong, M.D.
Organizational Affiliation
Department of Dermatology, National Taiwan University Hospital, Taipei, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Po-Yuan Wu, M.D., Ph.D.
Organizational Affiliation
Department of Dermatology, China Medical University Hospital, Taichung, Taiwan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis
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