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PsoriasisPhase 1NCT05522816

KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis

A Phase 1 study testing KX01 0.01% (0.1 mg/g), KX01 0.1% (1.0 mg/g) and KX01 1% (10 mg/g) for 5 days in people with Psoriasis, run by PharmaEssentia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Psoriasis
What is being tested?
KX01 0.01% (0.1 mg/g), KX01 0.1% (1.0 mg/g) and KX01 1% (10 mg/g) for 5 days
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
No sites listed yet
Study dates
27 Oct 2015to 10 Mar 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

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

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.

Read the detailed description

This is a Phase I dose escalation study to assess the safety, tolerability and activity of three different strengths of topical KX01 (Tirbanibulin Ointment) 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.

Conditions
Psoriasis
Being tested
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
Keywords
KX01, Ointment, Psoriasis, Phase I, Clinical trial
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KX01 0.01% (0.1 mg/g)Drug

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

  • PlaceboDrug

    Contains same excipients with KX01 but do not contain Tirbanibulin

  • KX01 0.1% (1.0 mg/g)Drug

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

  • KX01 1% (10 mg/g) for 5 daysDrug

    Stage 3: 6 patients (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 cyclesDrug

    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

Study groups in NCT05522816
Study groupRoleWhat they receive
KX01 0.01% in stage IExperimentalSix 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.
Receives: Drug: KX01 0.01% (0.1 mg/g)
Placebo in stage 1Placebo comparatorTwo 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.
Receives: Drug: Placebo
KX01 0.1% in stage 2ExperimentalSix patients in the stage 2 will receive KX01 0.1% (1.0 mg/g) for 4 weeks, followed by 2-week follow-up.
Receives: Drug: KX01 0.1% (1.0 mg/g)
Placebo in stage 2Placebo comparatorTwo patients in the stage 2 will receive placebo treatment for 4 weeks, followed by 2-week follow-up.
Receives: Drug: Placebo
KX01 1% for 5 days in stage 3ExperimentalSix 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.
Receives: 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 4ExperimentalSix 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.
Receives: Drug: KX01 1% (10 mg/g) for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse event at Stage 1

    Incidence of adverse event

    Measured: Day 50

  2. Adverse event at Stage 2

    Incidence of adverse event

    Measured: Day 43

  3. Adverse event at Stage 3

    Incidence of adverse event

    Measured: Day 29

  4. Adverse event at Stage 4

    Incidence of adverse event

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

  5. Local tolerability score at Stage 1

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

    Measured: Day 50

  6. Local tolerability score at Stage 2

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

    Measured: Day 43

  7. Local tolerability score at Stage 3

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

    Measured: Day 29

  8. Local tolerability score at Stage 4

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

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

  9. Vital signs at Stage 1

    any abnormal vital sign with clinical significance

    Measured: Day 50

  10. Vital signs at Stage 2

    any abnormal vital sign with clinical significance

    Measured: Day 43

  11. Vital signs at Stage 3

    any abnormal vital sign with clinical significance

    Measured: Day 29

  12. Vital signs at Stage 4

    any abnormal vital sign with clinical significance

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

  13. 12-lead ECG at Stage 1

    any abnormal finding of 12-lead ECG with clinical significance

    Measured: Day 36

  14. 12-lead ECG at Stage 2

    any abnormal finding of 12-lead ECG with clinical significance

    Measured: Day 29

  15. 12-lead ECG at Stage 3

    any abnormal finding of 12-lead ECG with clinical significance

    Measured: Day 29

  16. 12-lead ECG at Stage 4

    any abnormal finding of 12-lead ECG with clinical significance

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

  17. Hematology assessments at Stage 1

    any abnormal hematologic lab data with clinical significance

    Measured: Day 36

  18. Clinical chemistry assessments at Stage 1

    any abnormal chemical lab data with clinical significance

    Measured: Day 36

  19. Urinalysis assessments at Stage 1

    any abnormal urine lab data with clinically significant

    Measured: Day 36

  20. Hematology assessments at Stage 2

    any abnormal hematologic lab data with clinical significance

    Measured: Day 29

  21. Clinical chemistry assessments at Stage 2

    any abnormal chemical lab data with clinical significanc

    Measured: Day 29

  22. Urinalysis assessments at Stage 2

    any abnormal urine lab data with clinically significant

    Measured: Day 29

  23. Hematology assessments at Stage 3

    any abnormal hematologic lab data with clinical significance

    Measured: Day 29

  24. Clinical chemistry assessments at Stage 3

    any abnormal chemical lab data with clinical significanc

    Measured: Day 29

  25. Urinalysis assessments at Stage 3

    any abnormal urine lab data with clinically significant

    Measured: Day 29

  26. Hematology assessments at Stage 4

    any abnormal hematologic lab data with clinical significance

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

  27. Clinical chemistry assessments at Stage 4

    any abnormal chemical lab data with clinical significanc

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

  28. Urinalysis assessments at Stage 4

    any abnormal urine lab data with clinically significant

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

Secondary outcomes (19)

  1. 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)

    Measured: Stage 1: Up to Day 36

  2. 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

    Measured: Up to Day 29

  3. 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

    Measured: Up to Day 6

  4. 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

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

  5. TAS 50 at Stage 1

    ≧50% reduction in TAS score from baseline at the end of treatment

    Measured: Up to Day 36

  6. TAS 50 at Stage 2

    ≧50% reduction in TAS score from baseline at the end of treatment

    Measured: Up to Day 29

  7. TAS 50 at Stage 3

    ≧50% reduction in TAS score from baseline at the end of treatment

    Measured: Up to Day 6

  8. TAS 50 at Stage 4

    ≧50% reduction in TAS score from baseline at the end of treatment

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

  9. 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).

    Measured: Up to Day 36

  10. 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

    Measured: Up to Day 29

  11. 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

    Measured: Up to Day 6

  12. 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

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

  13. 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.

    Measured: Day 43

  14. 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.

    Measured: Day 15 and Day 29

  15. 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.

    Measured: 14 days after cycle 4 treatment and 28 days after cycle 4 treatment (each cycle is 7 days)

  16. Plasma KX01 concentrations (ng/ml) at Stage 1

    Detection of plasma KX01 concentrations (ng/ml)

    Measured: Up to Day 36

  17. Plasma KX01 concentrations (ng/ml) at Stage 2

    Detection of plasma KX01 concentrations (ng/ml)

    Measured: Up to Day 29

  18. Plasma KX01 concentrations (ng/ml) at Stage 3

    Detection of plasma KX01 concentrations (ng/ml)

    Measured: Up to Day 15

  19. Plasma KX01 concentrations (ng/ml) at Stage 4

    Detection of plasma KX01 concentrations (ng/ml)

    Measured: 14 days after cycle 4 treatment (each cycle is 7 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2022
  2. Study start27 Oct 2015
  3. Primary completion10 Mar 2021
  4. Study completion10 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05522816
Sponsor's protocol ID
B14-201
Status last verified
Aug 2022
First submitted
25 Aug 2022
Last updated
2 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KX01 0.01% (0.1 mg/g), KX01 0.1% (1.0 mg/g) and KX01 1% (10 mg/g) for 5 days in people with Psoriasis, run by PharmaEssentia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse event at Stage 1 (time frame: Day 50). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05522816.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.

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