Atopic DermatitisPhase 2NCT06085521
A Study of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing LNK01001 Dose A and LNK01001 Dose B in people with Atopic Dermatitis, run by Lynk Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice daily oral LNK01001 dose A or LNK01001 dose B or matching placebo for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- LNK01001 Dose A and LNK01001 Dose B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2022to 14 Jun 2023
- Phase
- Phase 2
- 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
- participants between ≥ 18 and ≤75 years of age.
- subjects meet Hanifin and Rajka criteria.
- subjects meet moderate to severe AD criteria.
- inadequate response to topical treatment or systemic treatment for AD within 6 months before screening.
Who cannot join
- current use of topical treatment for AD within 2 weeks before baseline visit.
- prior exposure to Janus Kinase (JAK) inhibitor.
- prior exposure to phototherapy, tanning bed, or any other light emitting device treatment within 4 weeks before baseline visit.
- Prior exposure to any Biologic treatment including Dupilumab, Omalizumab within 3 months before baseline visit.
- Any significant clinical and laboratory abnormalities, as determined by the Investigator, may affect the safety of the subjects, including but not limited to:WBC<3×10e9/L, neutrophil<1.2×10e9/L, platelet<100×10e9/L, hemoglobin<85 g/L; Aspartate aminotransferase or alanine aminotransferase>1.5×ULN, or total bilirubin>1.5×ULN; Serum creatinine>1.2×ULN.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficiency and Safety of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis
Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice daily oral LNK01001 dose A or LNK01001 dose B or matching placebo for 12 weeks.
Read the detailed description
The study was to include a 12-week double-blind treatment period. Participants who met eligibility criteria were to be randomized in a 1:1:1 ratio to one of the three treatment groups.
Group 1:LNK01001 dose A (Day 1 to Week 12) Group 2:LNK01001 dose B (Day 1 to Week 12) Group 3: Matching placebo (Day 1 to Week 12)
- Conditions
- Atopic Dermatitis
- Being tested
- LNK01001 Dose A, LNK01001 Dose B, placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNK01001 Dose ADrug
Capsules taken orally
LNK01001 Dose BDrug
Capsules taken orally
placeboDrug
Capsules taken orally
| Study group | Role | What they receive |
|---|---|---|
| LNK01001 Dose A | Experimental | Participants will receive LNK01001capsule Dose A BID orally for 12 weeks. Receives: Drug: LNK01001 Dose A |
| LNK01001 Dose B | Experimental | Participants will receive LNK01001capsule Dose B BID orally for 12 weeks. Receives: Drug: LNK01001 Dose B |
| placebo | Placebo comparator | Participants will receive a Placebo capsule BID orally for 12 weeks. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Eczema Area and Severity Index (EASI) Score
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Measured: week 12
Secondary outcomes (11)
Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75)
An EASI 75 response is defined as participants with at least a 75% reduction (improvement) in EASI score relative to the Baseline value
Measured: Week 4,8,12
Percentage of Participants Achieving an Investigator Global Assessment (IGA) response
IGA response defined as an IGA score of 0 (clear) or 1 (almost clear) with a reduction from baseline of ≥ 2 points
Measured: Week 4,8,12
Percent Change from Baseline in EASI Score
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).
The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
Measured: Week 4,8
Percentage of Participants Achieving a Reduction of ≥ 3 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS)
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Measured: Week 4,8,12
Change From Baseline in Worst Pruritus Numerical Rating Scale(NRS) Score
Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores.
Measured: Week 4,8,12
Percentage of Participants Achieving a Reduction of ≥ 2 Points From Baseline in Investigator Global Assessment (IGA)
IGA is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale:
0 - Clear: No inflammatory signs of AD;
- - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
- - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
- - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present;
- - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present.
Measured: Week 4,8,12
Percentage of Participants Who Achieved a 90% Reduction in EASI Score (EASI 90)
An EASI 90 response is defined as participants with at least a 90% reduction (improvement) in EASI score relative to the Baseline value
Measured: Week 4,8,12
Percentage of Participants Who Achieved a 50% Reduction in EASI Score (EASI 50)
An EASI 50 response is defined as participants with at least a 50% reduction (improvement) in EASI score relative to the Baseline value
Measured: Week 4,8,12
Percent Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Score
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst). A negative change from Baseline indicates improvement.
Measured: Week 4,8,12
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).
Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.
Measured: Week 4,8,12
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score
The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference.
Measured: Week 4,8,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start26 Jan 2022
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lynk Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085521
- Sponsor's protocol ID
- LK001202
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficiency and Safety of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06085521
- Acronym / sponsor ID
- LK001202
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Lynk Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 17 Oct 2023 (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.
Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice daily oral LNK01001 dose A or LNK01001 dose B or matching placebo for 12 weeks.
Detailed description
The study was to include a 12-week double-blind treatment period. Participants who met eligibility criteria were to be randomized in a 1:1:1 ratio to one of the three treatment groups.
Group 1:LNK01001 dose A (Day 1 to Week 12) Group 2:LNK01001 dose B (Day 1 to Week 12) Group 3: Matching placebo (Day 1 to Week 12)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LNK01001 Dose A | Experimental | Drug: LNK01001 Dose AParticipants will receive LNK01001capsule Dose A BID orally for 12 weeks. |
| LNK01001 Dose B | Experimental | Drug: LNK01001 Dose BParticipants will receive LNK01001capsule Dose B BID orally for 12 weeks. |
| placebo | Placebo comparator | Drug: placeboParticipants will receive a Placebo capsule BID orally for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- participants between ≥ 18 and ≤75 years of age.
- subjects meet Hanifin and Rajka criteria.
- subjects meet moderate to severe AD criteria.
- inadequate response to topical treatment or systemic treatment for AD within 6 months before screening.
Key exclusion criteria (5 listed)
- current use of topical treatment for AD within 2 weeks before baseline visit.
- prior exposure to Janus Kinase (JAK) inhibitor.
- prior exposure to phototherapy, tanning bed, or any other light emitting device treatment within 4 weeks before baseline visit.
- Prior exposure to any Biologic treatment including Dupilumab, Omalizumab within 3 months before baseline visit.
- Any significant clinical and laboratory abnormalities, as determined by the Investigator, may affect the safety of the subjects, including but not limited to:WBC<3×10e9/L, neutrophil<1.2×10e9/L, platelet<100×10e9/L, hemoglobin<85 g/L; Aspartate aminotransferase or alanine aminotransferase>1.5×ULN, or total bilirubin>1.5×ULN; Serum creatinine>1.2×ULN.
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 |
|---|---|---|
| LNK01001 Dose ACapsules taken orally | Drug | LNK01001 Dose A |
| LNK01001 Dose BCapsules taken orally | Drug | LNK01001 Dose B |
| placeboCapsules taken orally | Drug | placebo |
Primary outcome
Percent Change from Baseline in Eczema Area and Severity Index (EASI) Score
Time frame: week 12
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
11 secondary outcomes
Percentage of Participants Who Achieved a 75% Reduction in EASI Score (EASI 75)
Time frame: Week 4,8,12
Percentage of Participants Achieving an Investigator Global Assessment (IGA) response
Time frame: Week 4,8,12
Percent Change from Baseline in EASI Score
Time frame: Week 4,8
Percentage of Participants Achieving a Reduction of ≥ 3 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS)
Time frame: Week 4,8,12
Change From Baseline in Worst Pruritus Numerical Rating Scale(NRS) Score
Time frame: Week 4,8,12
Percentage of Participants Achieving a Reduction of ≥ 2 Points From Baseline in Investigator Global Assessment (IGA)
Time frame: Week 4,8,12
Percentage of Participants Who Achieved a 90% Reduction in EASI Score (EASI 90)
Time frame: Week 4,8,12
Percentage of Participants Who Achieved a 50% Reduction in EASI Score (EASI 50)
Time frame: Week 4,8,12
Percent Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Score
Time frame: Week 4,8,12
Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Time frame: Week 4,8,12
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score
Time frame: Week 4,8,12
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 27 Oct 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.
Jianzhong Zhang principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LNK01001 Dose A and LNK01001 Dose B 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 4 inclusion and 5 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 27 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent Change from Baseline in Eczema Area and Severity Index (EASI) Score (time frame: week 12). 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 27 Oct 2023.