Moderate to Severe Plaque PsoriasisPhase 1NCT05342428
Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis
A Phase 1 study testing TLL018 tablets in people with Moderate to Severe Plaque Psoriasis, run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 70 subjects with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- TLL018 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2022to 30 Aug 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had a diagnosis of moderate to severe plaque psoriasis for at least 6 months prior to Baseline;
- Subjects with moderate to severe plaque psoriasis covering ≥10% BSA, with a PASI ≥12 and sPGA score ≥3 at Baseline;
- Able and willing to give written informed consent.
Who cannot join
- Other types of psoriasis (such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, etc.);
- Current drug-induced psoriasis, e.g., a new onset of psoriasis or an exacerbation of psoriasis induced by beta blockers, calcium channel blockers, antimalarial drugs or lithium;
- History or symptoms of malignancy in any organ system regardless of treatment, and regardless of evidence of recurrence or metastasis;
- Any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province
Hangzhou, Zhejiang, 310009
About this study
Official title: A Phase Ⅰb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of TLL-018 in Subjects With Moderate to Severe Plaque Psoriasis
This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 70 subjects with moderate to severe plaque psoriasis.
Read the detailed description
Successfully screened subjects will be randomized in a ratio of 2:2:2:1 and stratified to previous biologics use for psoriasis.
After a 4-week screening period (day -28-0), subjects will be randomly assigned to treatment for 12 weeks.
Clinical psoriasis area and severity index (PASI), Physician's Global Assessment (PGA), dermatological Quality of Life Index (DLQI), physical exams and Laboratory tests will be performed at baseline, the end of weeks 4, 8 and 12 respectively.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- TLL018 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLL018 tabletsDrug
Also called TLL018 Placeboes
Oral tablets administered at different doses BID daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | TLL018 tablets, 1piece,BID Receives: Drug: TLL018 tablets |
| Cohort 2 | Experimental | TLL018 tablets, 2pieces, BID Receives: Drug: TLL018 tablets |
| Cohort 3 | Experimental | TLL018 tablets, 3pieces, BID Receives: Drug: TLL018 tablets |
| Cohort 4 | Placebo comparator | TLL018 placeboes, 3pieces, BID Receives: Drug: TLL018 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
Measured: From day 1 to Weeks 12
adverse events (AEs) according to severity
Number of adverse events (AEs) according to severity
Measured: From day 1 to Weeks 12
blood pressure from baseline
Change of blood pressure from baseline
Measured: From day 1 to Weeks 12
pulse rate from baseline
Change of pulse rate from baseline
Measured: From day 1 to Weeks 12
respiratory rate from baseline
Change of respiratory rate from baseline
Measured: From day 1 to Weeks 12
temperature from baseline
Change of oral temperature from baseline
Measured: From day 1 to Weeks 12
clinical laboratory abnormalities compared to baseline
Number of participants with clinical laboratory abnormalities compared to baseline
Measured: From day 1 to Weeks 12
ECG parameters from baseline
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
Measured: From day 1 to Weeks 12
physical examination findings from baseline
Number of participants with changes in physical examination findings from baseline
Measured: From day 1 to Weeks 12
Cmax of TLL018
Maximum observed plasma concentration (Cmax) of TLL018
Measured: 0 hour (pre-dose - within 30 minutes prior to dosing), and at 0.5, 1, 2, 4 and 12 hours post-dose
Secondary outcomes (6)
PASI score decreased from baseline at week 4
The percentage of subjects whose PASI score decreased by at least 50%(PASI 50) 75%(PASI 75) 90%(PASI 90) and 100%(PASI 100) from baseline at week 4 when comparing TLL-018 with placebo
Measured: Baseline to Week 4
PASI score decreased from baseline at week 8
The percentage of subjects whose PASI score decreased by at least 50%(PASI 50) 75%(PASI 75) 90%(PASI 90) and 100%(PASI 100) from baseline at week 8 when comparing TLL-018 with placebo
Measured: Baseline to Week 8
PASI score decreased from baseline at week 12
The percentage of subjects whose PASI score decreased by at least 50%(PASI 50) 75%(PASI 75) 90%(PASI 90) and 100%(PASI 100) from baseline at week 12 when comparing TLL-018 with placebo
Measured: Baseline to Week 12
(sPGA) 0/1 response at week 4
static Physician Global Assessment (sPGA) 0/1 response
Measured: Baseline to Weeks 4
(sPGA) 0/1 response at week 8
static Physician Global Assessment (sPGA) 0/1 response
Measured: Baseline to Weeks 8
(sPGA) 0/1 response at week 12
static Physician Global Assessment (sPGA) 0/1 response
Measured: Baseline to Weeks 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start10 Jun 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342428
- Sponsor's protocol ID
- TLL018-203
- Status last verified
- Jul 2023
- First submitted
- 7 Apr 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of TLL-018 in Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05342428
- Acronym / sponsor ID
- TLL018-203
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 70 subjects with moderate to severe plaque psoriasis.
Detailed description
Successfully screened subjects will be randomized in a ratio of 2:2:2:1 and stratified to previous biologics use for psoriasis.
After a 4-week screening period (day -28-0), subjects will be randomly assigned to treatment for 12 weeks.
Clinical psoriasis area and severity index (PASI), Physician's Global Assessment (PGA), dermatological Quality of Life Index (DLQI), physical exams and Laboratory tests will be performed at baseline, the end of weeks 4, 8 and 12 respectively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: TLL018 tabletsTLL018 tablets, 1piece,BID |
| Cohort 2 | Experimental | Drug: TLL018 tabletsTLL018 tablets, 2pieces, BID |
| Cohort 3 | Experimental | Drug: TLL018 tabletsTLL018 tablets, 3pieces, BID |
| Cohort 4 | Placebo comparator | Drug: TLL018 tabletsTLL018 placeboes, 3pieces, BID |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have had a diagnosis of moderate to severe plaque psoriasis for at least 6 months prior to Baseline;
- Subjects with moderate to severe plaque psoriasis covering ≥10% BSA, with a PASI ≥12 and sPGA score ≥3 at Baseline;
- Able and willing to give written informed consent.
Key exclusion criteria (4 listed)
- Other types of psoriasis (such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, etc.);
- Current drug-induced psoriasis, e.g., a new onset of psoriasis or an exacerbation of psoriasis induced by beta blockers, calcium channel blockers, antimalarial drugs or lithium;
- History or symptoms of malignancy in any organ system regardless of treatment, and regardless of evidence of recurrence or metastasis;
- Any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the subject's participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLL018 tabletsAlso: TLL018 PlaceboesOral tablets administered at different doses BID daily for 12 weeks. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
Time frame: From day 1 to Weeks 12
Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
adverse events (AEs) according to severity
Time frame: From day 1 to Weeks 12
Number of adverse events (AEs) according to severity
blood pressure from baseline
Time frame: From day 1 to Weeks 12
Change of blood pressure from baseline
pulse rate from baseline
Time frame: From day 1 to Weeks 12
Change of pulse rate from baseline
respiratory rate from baseline
Time frame: From day 1 to Weeks 12
Change of respiratory rate from baseline
temperature from baseline
Time frame: From day 1 to Weeks 12
Change of oral temperature from baseline
clinical laboratory abnormalities compared to baseline
Time frame: From day 1 to Weeks 12
Number of participants with clinical laboratory abnormalities compared to baseline
ECG parameters from baseline
Time frame: From day 1 to Weeks 12
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
physical examination findings from baseline
Time frame: From day 1 to Weeks 12
Number of participants with changes in physical examination findings from baseline
Cmax of TLL018
Time frame: 0 hour (pre-dose - within 30 minutes prior to dosing), and at 0.5, 1, 2, 4 and 12 hours post-dose
Maximum observed plasma concentration (Cmax) of TLL018
6 secondary outcomes
PASI score decreased from baseline at week 4
Time frame: Baseline to Week 4
PASI score decreased from baseline at week 8
Time frame: Baseline to Week 8
PASI score decreased from baseline at week 12
Time frame: Baseline to Week 12
(sPGA) 0/1 response at week 4
Time frame: Baseline to Weeks 4
(sPGA) 0/1 response at week 8
Time frame: Baseline to Weeks 8
(sPGA) 0/1 response at week 12
Time frame: Baseline to Weeks 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TLL018 tablets in people with Moderate to Severe Plaque Psoriasis, run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.
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 3 inclusion and 4 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs (time frame: From day 1 to Weeks 12). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2023.