Atopic DermatitisPhase 1NCT06553287
Safety, Tolerability and Pharmacokinetics of LNK01004 Ointment in Adults With Atopic Dermatitis.
A Phase 1 study testing LNK01004 ointment 0.3%, LNK01004 ointment 1.0% and LNK01004 ointment 1.5% in people with Atopic Dermatitis, run by Lynk Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
The purpose of the study is to evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment (0.3%, 1.0%, and 1.5%) vs vehicle twice daily (BID) in Adults Patients with Atopic Dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LNK01004 ointment 0.3%, LNK01004 ointment 1.0% and LNK01004 ointment 1.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2023to 18 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants were diagnosed with atopic dermatitis (AD) for at least 6 months.
- Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline.
- Participants with body surface area (BSA) of AD involvement, excluding the scalp, face, and intertriginous areas, of 3% to 20% at screening and baseline.
- BMI of 18.0-30.0 kg/m2, with body weight ≥ 50 kg for man and ≥ 40 kg for woman.
- Be willing to comply with the study lifestyle restraints, e.g., no washing of the administered area within 6 hours of study drug administration, no sweaty exercise.
Who cannot join
- Participants with a physical condition which, in the Investigator´s opinion, might interfere with the assessment of atopic dermatitis or expose the patient to an unacceptable risk by study participation.
- Participants with current evidence of any acute skin infection with a history of recurrent or chronic severe skin infection.
- Participants with known allergies to components or excipients of the test drug.
- Participants who are pregnant, nursing, or planning a pregnancy during the study period.
- Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, mycophenolate mofetil, PDE4 inhibitor) used for atopic dermatitis within 4 weeks or 5 half-lives of baseline (whichever is longer).
- Participants with the following hematologic abnormities at screening:
Show all 13Show fewer
- Leukocytes < 3.0 × 10^9/L.
- Neutrophils < lower limit of normal.
- Hemoglobin < 10 g/dL.
- Lymphocytes < 0.8 × 10^9/L
- Platelets < 100 × 10^9/L.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal.
- TBiL ≥ 1.5 × ULN, or ULN < TBiL < 1.5 × ULN but judged by the investigator to be abnormal clinically significant;
Trial locations and contacts
1 site in 1 country.
China1 site
Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences.
Nanjing
About this study
Official title: A Phase Ib, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 Ointment in Adults Patients With Mild to Moderate Atopic Dermatitis.
The purpose of the study is to evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment (0.3%, 1.0%, and 1.5%) vs vehicle twice daily (BID) in Adults Patients with Atopic Dermatitis.
Read the detailed description
This is a multicenter, randomized, double-blind, vehicle-controlled, dose-escalation study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment twice daily (BID) in participants with Mild to Moderate atopic dermatitis as compared with vehicle cream BID.
- Conditions
- Atopic Dermatitis
- Being tested
- LNK01004 ointment 0.3%, LNK01004 ointment 1.0%, LNK01004 ointment 1.5%, Vehicle BID
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNK01004 ointment 0.3%Drug
LNK01004 ointment 0.3% for topical application
LNK01004 ointment 1.0%Drug
LNK01004 ointment 1.0% for topical application
LNK01004 ointment 1.5%Drug
LNK01004 ointment 1.5% for topical application
Vehicle BIDDrug
Inactive vehicle matched to LNK01004 ointment for topical application.
| Study group | Role | What they receive |
|---|---|---|
| LNK01004 ointment 0.3% | Experimental | Participants will receive LNK01004 ointment 0.3% twice daily Receives: Drug: LNK01004 ointment 0.3% |
| LNK01004 ointment 1.0% | Experimental | Participants will receive LNK01004 ointment 1.0% twice daily Receives: Drug: LNK01004 ointment 1.0% |
| LNK01004 ointment 1.5% | Experimental | Participants will receive LNK01004 ointment 1.5% twice daily Receives: Drug: LNK01004 ointment 1.5% |
| Vehicle | Experimental | Participants will receive vehicle BID Receives: Drug: Vehicle BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emergent Adverse Events (TEAE)
Number of participants with at least one TEAE.
Measured: Baseline up to week 4
Secondary outcomes (6)
Maximum concentration (Cmax) for LNK01004 in plasma
Cmax is defined as the maximum observed plasma concentration for LNK01004
Measured: Day1 and Day 7
Area under plasma concentration versus time curve, time zero to infinity
The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma
Measured: Day 1 and Day7
Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score
The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Measured: Baseline and Weeks 1, 2, and 4
Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75)
The number of participants with a decrease of at least 75% from the baseline EASI total score is presented. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease), with positive results indicating an increase from baseline in EASI total score (i.e., increased symptoms) and negative results indicating a decrease from baseline score (i.e., decreased symptoms). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Measured: Baseline and Weeks 1, 2, and 4
Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score
The number of participants achieving a ≥4-point improvement from Baseline in WI-NRS score is presented. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Higher scores indicate greater symptom severity.
Measured: Baseline and Weeks 1, 2, and 4
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.
Measured: Baseline and Weeks 1, 2, and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start12 Jul 2023
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lynk Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qianjin Lu, Principal investigator, Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553287
- Sponsor's protocol ID
- LK004102
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 14 Aug 2024
- 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 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 Ointment in Adults Patients With Mild to Moderate Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT06553287
- Acronym / sponsor ID
- LK004102
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Lynk Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 14 Aug 2024 (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.
The purpose of the study is to evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment (0.3%, 1.0%, and 1.5%) vs vehicle twice daily (BID) in Adults Patients with Atopic Dermatitis.
Detailed description
This is a multicenter, randomized, double-blind, vehicle-controlled, dose-escalation study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LNK01004 ointment twice daily (BID) in participants with Mild to Moderate atopic dermatitis as compared with vehicle cream BID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LNK01004 ointment 0.3% | Experimental | Drug: LNK01004 ointment 0.3%Participants will receive LNK01004 ointment 0.3% twice daily |
| LNK01004 ointment 1.0% | Experimental | Drug: LNK01004 ointment 1.0%Participants will receive LNK01004 ointment 1.0% twice daily |
| LNK01004 ointment 1.5% | Experimental | Drug: LNK01004 ointment 1.5%Participants will receive LNK01004 ointment 1.5% twice daily |
| Vehicle | Experimental | Drug: Vehicle BIDParticipants will receive vehicle BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants were diagnosed with atopic dermatitis (AD) for at least 6 months.
- Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline.
- Participants with body surface area (BSA) of AD involvement, excluding the scalp, face, and intertriginous areas, of 3% to 20% at screening and baseline.
- BMI of 18.0-30.0 kg/m2, with body weight ≥ 50 kg for man and ≥ 40 kg for woman.
- Be willing to comply with the study lifestyle restraints, e.g., no washing of the administered area within 6 hours of study drug administration, no sweaty exercise.
Key exclusion criteria (13 listed)
- Participants with a physical condition which, in the Investigator´s opinion, might interfere with the assessment of atopic dermatitis or expose the patient to an unacceptable risk by study participation.
- Participants with current evidence of any acute skin infection with a history of recurrent or chronic severe skin infection.
- Participants with known allergies to components or excipients of the test drug.
- Participants who are pregnant, nursing, or planning a pregnancy during the study period.
- Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, mycophenolate mofetil, PDE4 inhibitor) used for atopic dermatitis within 4 weeks or 5 half-lives of baseline (whichever is longer).
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 |
|---|---|---|
| LNK01004 ointment 0.3%LNK01004 ointment 0.3% for topical application | Drug | LNK01004 ointment 0.3% |
| LNK01004 ointment 1.0%LNK01004 ointment 1.0% for topical application | Drug | LNK01004 ointment 1.0% |
| LNK01004 ointment 1.5%LNK01004 ointment 1.5% for topical application | Drug | LNK01004 ointment 1.5% |
| Vehicle BIDInactive vehicle matched to LNK01004 ointment for topical application. | Drug | Vehicle |
Primary outcome
Treatment-Emergent Adverse Events (TEAE)
Time frame: Baseline up to week 4
Number of participants with at least one TEAE.
6 secondary outcomes
Maximum concentration (Cmax) for LNK01004 in plasma
Time frame: Day1 and Day 7
Area under plasma concentration versus time curve, time zero to infinity
Time frame: Day 1 and Day7
Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score
Time frame: Baseline and Weeks 1, 2, and 4
Number of Participants Achieving a 75% Decrease From Baseline in EASI Score (EASI-75)
Time frame: Baseline and Weeks 1, 2, and 4
Number of Participants Achieving ≥4-Point Improvement in WI-NRS Pruritus Score
Time frame: Baseline and Weeks 1, 2, and 4
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline
Time frame: Baseline and Weeks 1, 2, and 4
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 14 Aug 2024.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
Qianjin Lu principal investigator
Hospital for skin diseases, Institute of Dermatology, Chinese Academy of Medical Sciences.
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 LNK01004 ointment 0.3%, LNK01004 ointment 1.0% and LNK01004 ointment 1.5% in people with Atopic Dermatitis, run by Lynk Pharmaceuticals 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 5 inclusion and 13 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 14 Aug 2024. 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. 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 (TEAE) (time frame: Baseline up to week 4). 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 14 Aug 2024.