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

NCT04090229 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ASLAN004-002
• Study Type: interventional
• Target: 52
• Locations: 3 countries
• Sites: 11

Brief Summary

A Phase 1B, multi-center, double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) clinical study is designed to evaluate ASLAN004 versus placebo in patients who have moderate-severe AD. The treatment period duration will be 8 weeks with a 12-week follow-up period after the end of treatment.

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

Study Arms (2)

ASLAN004

EXPERIMENTAL

Drug: ASLAN004

ASLAN004 Placebo

PLACEBO COMPARATOR

Drug: ASLAN004 Placebo

Interventions

ASLAN004 DRUG

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 Placebo DRUG

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• 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.
• Have an IGA score of ≥3 at the screening and baseline visits.
• Have ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits.
• Have an EASI score ≥16 at the screening and baseline visits.
• 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.
• Have applied a stable dose of an additive, basic, bland topical emollient (moisturizer) twice daily for at least 7 days before Randomization.

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.

Sponsors & Collaborators

• ASLAN Pharmaceuticals: lead

Study Sites (11)

Center for Dermatology Clinical Research, INC

Fremont, California, 94538, United States

Location

First OC Dermatology

Los Angeles, California, 92708, United States

Location

Direct Helpers Research Center

Miami, Florida, 33012, United States

Location

Paddington Testing Co, INC

Philadelphia, Pennsylvania, 19103, United States

Location

Dermatology Treatment and Research Cancer

Dallas, Texas, 75230, United States

Location

Premier Specialists Pty Ltd

Kogarah, New South Wales, 2217, Australia

Location

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, 4102, Australia

Location

Skin Health Institute, Inc.

Carlton, Victoria, 3053, Australia

Location

Fremantle Dermatology

Fremantle, Western Australia, 6160, Australia

Location

National Skin Centre

Singapore, 308205, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

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: 39404994 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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

Model Details: Double Blind, Placebo-controlled, Randomized

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 16, 2019
• Study Start: September 9, 2019
• Primary Completion: October 28, 2021
• Study Completion: December 3, 2021
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2); US (5); AU (4)