KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis

NCT05522816 | Completed Phase 1

• 1 other identifier: B14-201
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

KX01; Ointment; Psoriasis; Phase I; Clinical trial

Outcome Measures

Primary Outcomes (28)

• Adverse event at Stage 1

  Incidence of adverse event

  Day 50

• Adverse event at Stage 2

  Incidence of adverse event

  Day 43

• Adverse event at Stage 3

  Incidence of adverse event

  Day 29

• Adverse event at Stage 4

  Incidence of adverse event

  28 days after the end of cycle 4 treatment (each cycle is 7 days)

• Local tolerability score at Stage 1

  4-point (0-3) rating scale; higher scores mean a worse outcome

  Day 50

• Local tolerability score at Stage 2

  4-point (0-3) rating scale; higher scores mean a worse outcome

  Day 43

• Local tolerability score at Stage 3

  4-point (0-3) rating scale; higher scores mean a worse outcome

  Day 29

• Local tolerability score at Stage 4

  4-point (0-3) rating scale; higher scores mean a worse outcome

  28 days after the end of cycle 4 treatment (each cycle is 7 days)

• Vital signs at Stage 1

  any abnormal vital sign with clinical significance

  Day 50

• Vital signs at Stage 2

  any abnormal vital sign with clinical significance

  Day 43

• Vital signs at Stage 3

  any abnormal vital sign with clinical significance

  Day 29

• Vital signs at Stage 4

  any abnormal vital sign with clinical significance

  28 days after the end of cycle 4 treatment (each cycle is 7 days)

• 12-lead ECG at Stage 1

  any abnormal finding of 12-lead ECG with clinical significance

  Day 36

• 12-lead ECG at Stage 2

  any abnormal finding of 12-lead ECG with clinical significance

  Day 29

• 12-lead ECG at Stage 3

  any abnormal finding of 12-lead ECG with clinical significance

  Day 29

• 12-lead ECG at Stage 4

  any abnormal finding of 12-lead ECG with clinical significance

  28 days after the end of cycle 4 treatment (each cycle is 7 days)

• Hematology assessments at Stage 1

  any abnormal hematologic lab data with clinical significance

  Day 36

• Clinical chemistry assessments at Stage 1

  any abnormal chemical lab data with clinical significance

  Day 36

• Urinalysis assessments at Stage 1

  any abnormal urine lab data with clinically significant

  Day 36

• Hematology assessments at Stage 2

  any abnormal hematologic lab data with clinical significance

  Day 29

• Clinical chemistry assessments at Stage 2

  any abnormal chemical lab data with clinical significanc

  Day 29

• Urinalysis assessments at Stage 2

  any abnormal urine lab data with clinically significant

  Day 29

• Hematology assessments at Stage 3

  any abnormal hematologic lab data with clinical significance

  Day 29

• Clinical chemistry assessments at Stage 3

  any abnormal chemical lab data with clinical significanc

  Day 29

• Urinalysis assessments at Stage 3

  any abnormal urine lab data with clinically significant

  Day 29

• Hematology assessments at Stage 4

  any abnormal hematologic lab data with clinical significance

  28 days after the end of cycle 4 treatment (each cycle is 7 days)

• Clinical chemistry assessments at Stage 4

  any abnormal chemical lab data with clinical significanc

  28 days after the end of cycle 4 treatment (each cycle is 7 days)

• Urinalysis assessments at Stage 4

  any abnormal urine lab data with clinically significant

  28 days after the end of cycle 4 treatment (each cycle is 7 days)

Secondary Outcomes (19)

• Change between baseline and end of treatment in target area score (TAS) at Stage 1

  Stage 1: Up to Day 36

• Change between baseline and end of TAS at Stage 2

  Up to Day 29

• Change between baseline and end of TAS at Stage 3

  Up to Day 6

• Change between baseline and end of TAS at Stage 4

  Up to the end of cycle 4 treatment (each cycle is 7 days)

• TAS 50 at Stage 1

  Up to Day 36

Study Arms (6)

KX01 0.01% in stage I

EXPERIMENTAL

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.

Drug: KX01 0.01% (0.1 mg/g)

Placebo in stage 1

PLACEBO COMPARATOR

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.

Drug: Placebo

KX01 0.1% in stage 2

EXPERIMENTAL

Six patients in the stage 2 will receive KX01 0.1% (1.0 mg/g) for 4 weeks, followed by 2-week follow-up.

Drug: KX01 0.1% (1.0 mg/g)

Placebo in stage 2

PLACEBO COMPARATOR

Two patients in the stage 2 will receive placebo treatment for 4 weeks, followed by 2-week follow-up.

Drug: Placebo

KX01 1% for 5 days in stage 3

EXPERIMENTAL

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.

Drug: KX01 1% (10 mg/g) for 5 days

KX01 1% for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles in stage 4

EXPERIMENTAL

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.

Drug: KX01 1% (10 mg/g) for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles

Interventions

KX01 0.01% (0.1 mg/g) DRUG

Stage 1: 6 patients (KX01 0.01% \[0.1 mg/g\])

KX01 0.01% in stage I

Placebo DRUG

Contains same excipients with KX01 but do not contain Tirbanibulin

Placebo in stage 1; Placebo in stage 2

KX01 0.1% (1.0 mg/g) DRUG

Stage 2: 6 patients (KX01 0.1% \[1.0 mg/g\])

KX01 0.1% in stage 2

KX01 1% (10 mg/g) for 5 days DRUG

Stage 3: 6 patients (KX01 1% \[10 mg/g\]) for 5 days

KX01 1% for 5 days in stage 3

KX01 1% (10 mg/g) for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles DRUG

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

KX01 1% for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles in stage 4

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PharmaEssentia: lead

MeSH Terms

Conditions

Psoriasis

Interventions

tirbanibulin; RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jin-Bon Hong, M.D.

  Department of Dermatology, National Taiwan University Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

• Po-Yuan Wu, M.D., Ph.D.

  Department of Dermatology, China Medical University Hospital, Taichung, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 31, 2022
• Study Start: October 27, 2015
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: July 2, 2025

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share