Trials Sponsors Conditions Drugs Pricing

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

To assess the safety and tolerability of multiple ascending doses of ASLAN004: Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs) reported from the administration of study drug on Day 1 until the completion of the study.
Baseline to 12 weeks safety follow up

Secondary Outcomes (10)

Percentage change from baseline in Eczema Area and Severity Index (EASI) score weekly up to Week 8.
Baseline up to Week 8
Proportion of patients with 50%, 75%, and 90% improvement in the EASI score (EASI50, EASI75, and EASI90) weekly up to Week 8.
Baseline up to Week 8
Percentage change from baseline in the Pruritus Numerical Rating Scale (NRS) score weekly up to Week 8.
Baseline up to Week 8
Proportion of patients with at least a 4-point improvement in the Pruritus NRS score weekly up to Week 8.
Baseline up to Week 8
Proportion of patients who achieve an Investigator Global Assessment (IGA) score of 0 or 1 weekly up to Week 8.
Baseline up to Week 8
+5 more secondary outcomes

Study Arms (2)

ASLAN004

EXPERIMENTAL

Drug: ASLAN004

ASLAN004 Placebo

PLACEBO COMPARATOR

Drug: ASLAN004 Placebo

Interventions

ASLAN004Drug

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.

ASLAN004

ASLAN004 PlaceboDrug

Subcutaneous injections of ASLAN004 Placebo will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel.

ASLAN004 Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
Willing and able to comply with clinic visits and study-related procedures.

Sponsors & Collaborators

ASLAN Pharmaceuticals
Otherlead

Study Sites (11)

Center for Dermatology Clinical Research, INC

Fremont, California, 94538, United States

First OC Dermatology

Los Angeles, California, 92708, United States

Direct Helpers Research Center

Miami, Florida, 33012, United States

Paddington Testing Co, INC

Philadelphia, Pennsylvania, 19103, United States

Dermatology Treatment and Research Cancer

Dallas, Texas, 75230, United States

Premier Specialists Pty Ltd

Kogarah, New South Wales, 2217, Australia

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, 4102, Australia

Related Publications (1)

Cevikbas F, Ward A, Veverka KA. Eblasakimab, an Anti-IL-13Ralpha1 Antibody, Reduces Atopy-Associated Serum Biomarkers in Moderate-to-Severe Atopic Dermatitis. BioDrugs. 2024 Nov;38(6):821-830. doi: 10.1007/s40259-024-00685-y. Epub 2024 Oct 15.
PMID: 39404994DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Enrollment

52 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 16, 2019

Study Start

September 9, 2019

Actual (reported)

You may not qualify if:

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.
Have inadequate organ and hematological function at the screening visit (as per protocol)
Have uncontrolled blood pressure at the screening visit based on clinical judgment of the Investigator.
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.
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.
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).
Have received treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before Randomization.
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.
Have had systemic treatment for AD with cyclosporine, mycophenolate-mofetil, interferon gamma (IFN-γ), phototherapy (narrow band ultraviolet B \[NBUVB\], ultraviolet B \[UVB\], ultraviolet A1 \[UVA1\], psoralen + ultraviolet A \[PUVA\]), azathioprine, or methotrexate within 4 weeks before Randomization.
Have had treatment with leukotriene inhibitors within 4 weeks before Randomization.
Have had treatment with systemic corticosteroids within 4 weeks before Randomization.
Have had treatment with small molecule investigational drugs (eg., tofacitinib) within 8 weeks before Randomization.
Have had treatment with biologics other than those targeting ligand or receptors of IL-4 or IL-13 within 8 weeks before Randomization.
Have had treatment with live attenuated vaccine within 8 weeks before Randomization.
Have had treatment with allergen immunotherapy within 6 months before Randomization.
+12 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

ASLAN004

ASLAN004 Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

ASLAN004

ASLAN004 Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations