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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04090229




Registration number
NCT04090229
Ethics application status
Date submitted
11/09/2019
Date registered
16/09/2019

Titles & IDs
Public title
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis
Scientific title
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis
Secondary ID [1] 0 0
ASLAN004-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ASLAN004
Treatment: Drugs - ASLAN004 Placebo

Experimental: ASLAN004 -

Placebo comparator: ASLAN004 Placebo -


Treatment: Drugs: ASLAN004
Subcutaneous injections of ASLAN004 100 mg/mL will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel.

Treatment: Drugs: ASLAN004 Placebo
Subcutaneous injections of ASLAN004 Placebo will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the safety and tolerability of multiple ascending doses of ASLAN004: Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Baseline to 12 weeks safety follow up
Secondary outcome [1] 0 0
Percentage change from baseline in Eczema Area and Severity Index (EASI) score weekly up to Week 8.
Timepoint [1] 0 0
Baseline up to Week 8
Secondary outcome [2] 0 0
Proportion of patients with 50%, 75%, and 90% improvement in the EASI score (EASI50, EASI75, and EASI90) weekly up to Week 8.
Timepoint [2] 0 0
Baseline up to Week 8
Secondary outcome [3] 0 0
Percentage change from baseline in the Pruritus Numerical Rating Scale (NRS) score weekly up to Week 8.
Timepoint [3] 0 0
Baseline up to Week 8
Secondary outcome [4] 0 0
Proportion of patients with at least a 4-point improvement in the Pruritus NRS score weekly up to Week 8.
Timepoint [4] 0 0
Baseline up to Week 8
Secondary outcome [5] 0 0
Proportion of patients who achieve an Investigator Global Assessment (IGA) score of 0 or 1 weekly up to Week 8.
Timepoint [5] 0 0
Baseline up to Week 8
Secondary outcome [6] 0 0
Percentage change from baseline in the Patient-Oriented Eczema Measure (POEM) weekly up to Week 8.
Timepoint [6] 0 0
Baseline up to Week 8
Secondary outcome [7] 0 0
Percentage change from baseline in percent body surface area (%BSA) affected weekly up to Week 8.
Timepoint [7] 0 0
Baseline up to Week 8
Secondary outcome [8] 0 0
PK parameters throughout the dosing period, and serum concentrations by scheduled timepoints.
Timepoint [8] 0 0
Baseline to 12 weeks safety follow up
Secondary outcome [9] 0 0
Change from baseline in PD markers of allergic inflammation (TARC and total IgE) weekly up to Week 8.
Timepoint [9] 0 0
Baseline up to Week 8
Secondary outcome [10] 0 0
Measurement of ASLAN004 Anti-Drug Antibody over time.
Timepoint [10] 0 0
Baseline to 12 weeks safety follow up

Eligibility
Key inclusion criteria
1. Adult patients who are of or older than the legal age in participating countries, who are able to read and understand, and willing to sign the informed consent form.
2. Willing and able to comply with clinic visits and study-related procedures.
3. Have a clinical diagnosis of chronic atopic dermatitis (per Eichenfield revised criteria of Hanifin and Rajka) that has been present for at least 3 years before the screening visit.
4. Have an IGA score of =3 at the screening and baseline visits.
5. Have =10% body surface area (BSA) of AD involvement at the screening and baseline visits.
6. Have an EASI score =16 at the screening and baseline visits.
7. Have a history of inadequate response to a stable (=1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.
8. Have applied a stable dose of an additive, basic, bland topical emollient (moisturizer) twice daily for at least 7 days before Randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have received previous treatment with therapeutic agents targeting ligand or receptors of IL-4 or IL-13, including but not limited to dupilumab, lebrikizumab, or tralokinumab.
2. Have inadequate organ and hematological function at the screening visit (as per protocol)
3. Have uncontrolled blood pressure at the screening visit based on clinical judgment of the Investigator.
4. Have a chest radiograph at Screening or within 3 months before the screening visit with results consistent with prior or current tuberculosis infection (including but not limited to apical scarring, apical fibrosis, or multiple calcified granuloma). This does not include non caseating granulomata. QuantiFERON gold standard may be conducted per standard practice at the site.
5. Have a known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection or positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody HBcAb), positive Hepatitis C antibody (HCV) at the screening visit.
6. Have a known or suspected history of immunosuppression, including history of invasive opportunistic infections such as tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jiroveci, aspergillosis despite infection resolution; JC virus (progressive multifocal leukoencephalopathy).
7. Have received treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before Randomization.
8. Have received treatment with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products (eg., Atopiclair®, MimyX®, Epicerum®, Cerave®, etc) within 1 week before Randomization.
9. Have had systemic treatment for AD with cyclosporine, mycophenolate-mofetil, interferon gamma (IFN-?), phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), azathioprine, or methotrexate within 4 weeks before Randomization.
10. Have had treatment with leukotriene inhibitors within 4 weeks before Randomization.
11. Have had treatment with systemic corticosteroids within 4 weeks before Randomization.
12. Have had treatment with small molecule investigational drugs (eg., tofacitinib) within 8 weeks before Randomization.
13. Have had treatment with biologics other than those targeting ligand or receptors of IL-4 or IL-13 within 8 weeks before Randomization.
14. Have had treatment with live attenuated vaccine within 8 weeks before Randomization.
15. Have had treatment with allergen immunotherapy within 6 months before Randomization.
16. Have had a regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
17. Requirement of more than 2 bleach baths per week during study participation.
18. Have chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the screening visit, or superficial skin infections within 1 week before the screening visit.
19. Presence of skin comorbidities that may interfere with study assessments.
20. Have a clinically significant history or evidence of any active or suspected parasitic infection (other than treated trichomoniasis) within the 4 weeks before Randomization or has travelled within the past 3 months of Randomization to areas of high parasitic exposure (based on Centers for Disease Control and Prevention [CDC] travel notice alert Level 2 and warning Level 3).
21. Have a history of malignancy within 5 years before Randomization with the following exceptions: patient with a history of cured in situ carcinoma of the cervix, and/or non-metastatic squamous or basal cell carcinoma of the skin are allowed.
22. Have any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor's Medical Monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results.
23. Have a history of alcohol or drug abuse within 2 years of the screening visit.
24. Have scheduled or anticipate any surgical procedure during study participation and/or hospitalization for any reason within 60 days of Screening.
25. Pregnant or breastfeeding women.
26. Patients who are unwilling to use adequate birth control, if of reproductive potential and sexually active. For females, adequate birth control implies: use of hormonal contraceptives, intrauterine devices (IUD), or double barrier contraception (condom + diaphragm, condom or diaphragm + spermicidal gel or foam). For males, adequate birth control implies: use of double barrier contraception (condom + diaphragm, condom or diaphragm + spermicidal gel or foam). Abstinence is also accepted if this is the normal habit of the patient.
27. Patients who are dependent on prescription moisturizers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/12/2021
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Premier Specialists Pty Ltd - Kogarah
Recruitment hospital [2] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment hospital [3] 0 0
Skin Health Institute, Inc. - Carlton
Recruitment hospital [4] 0 0
Fremantle Dermatology - Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Singapore
State/province [5] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
ASLAN Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04090229