A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated with Dupilumab.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aslan Pharmaceuticals Pte Ltd

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2024-05-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Aslan Pharmaceuticals Pte. Ltd

External identifiers

EU CT number

2023-508329-28-00

ClinicalTrials.gov

NCT05694884

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety, Others

To evaluate the efficacy of eblasakimab in participants with moderate-to severe AD previously treated with dupilumab.

Secondary objectives 1

1. To evaluate safety and tolerability of eblasakimab in participants with moderate-to-severe AD previously treated with dupilumab.

Conditions and MedDRA coding

Atopic Dermatitis

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Male or female participants ≥18 years old;
2. 2. Willing and able to comply with clinic visits and study-related procedures;
3. 3. Chronic AD present for at least 1 year prior to the Screening visit;
4. 4. Have a vIGA score of ≥3 (5-point scale, 0-4) at the Baseline;
5. 5. Have ≥10% BSA of AD involvement at the Baseline;
6. 6. Have an EASI score ≥18 at the Screening and Baseline visits.
7. 7. History of inadequate response to, intolerance to or contraindication to a stable regimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) as treatment for AD
8. 8. All participants must have previously been treated with dupilumab meeting one of the following conditions: -Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab for at least 16 weeks duration; -Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment; -Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab or for any other reasons may enter the study with no required prior length of dupilumab treatment

Exclusion criteria 11

1. 1. Use of immunosuppressive/immunomodulating drugs and/or therapies, JAK inhibitors, or phototherapy (including tanning booth/parlor) within 4 weeks prior to the Baseline visit;
2. 2. Have an uncontrolled chronic disease that may require multiple intermittent use of systemic corticosteroids at Screening, as defined by the Investigator;
3. 3. Have uncontrolled asthma that might require bursts of oral or systemic corticosteriods, or require either of the following due to ≥1 exacerbations within 12 months before Baseline: -Systemic (oral and/or parenteral) corticosteroid treatment; -Hospitalization for >24 hours;
4. 4. Have had systemic treatment with small molecule investigational drugs within 8 weeks or 5 half-lives (if known), whichever is longer, prior to the Baseline visit
5. 5. Have received treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI) such as tacrolimus and pimecrolimus, topical phosphodiesterase inhibitors such as crisaborole, topical JAK inhibitors (commercial or investigational use), within 1 week prior to randomization
6. 6. Have inadequate organ function or abnormal lab results considered clinically significant by the Investigator at the Screening visit
7. 7. History of human immunodeficiency virus (HIV) or positive HIV serology at Screening
8. 8. Infected with hepatitis B or hepatitis C viruses. For Hepatitis B, all subjects will undergo testing for Hepatitis B Surface Antigen (HBsAg) and Hepatitis B Core Antibody (HBcAb) during Screening. Subjects who are HBsAg positive are not eligible for the study. Subjects who are HBsAg negative and HBcAb positive will be tested for Hepatitis B Surface Antibody (HBsAb) and if HBsAb is positive, may be enrolled in the study; if HBsAb is negative, the subject is not eligible for the study. For Hepatitis C, all subjects will undergo testing for Hepatitis C antibody (HCVAb) during Screening. Subjects who are HCVAb positive are not eligible for the study. Active COVID-19 infection at Baseline.
9. 9. Have known liver cirrhosis and/or chronic hepatitis of any etiology
10. 10. Known diagnosis of active tuberculosis or non-tuberculous mycobacterial infection or latent tuberculosis unless it is well documented by a specialist that the patient has been adequately treated
11. 11. Allergen immunotherapy should be discontinued 6 months before randomization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage change in EASI score from Baseline to Week 16

Secondary endpoints 15

1. • Proportion of participants achieving vIGA response of 0 (clear) or 1 (almost clear) [5-point scale] at Week 16
2. • Proportion of participants with a 75% reduction from Baseline in EASI (EASI 75) at Week 16
3. • Proportion of participants achieving EASI 50 and EASI 90 at Week 16
4. • Proportion of participants with EASI <7 at Week 16
5. • Absolute and percent change in peak P-NRS from Baseline to Week 16
6. • Proportion of participants achieving a 4-point reduction in peak PNRS at Week 16
7. • Change in BSA affected with AD from Baseline to Week 16
8. • Change in SCORAD from Baseline to Week 16
9. • Change in DLQI from Baseline to Week 16
10. • Change in POEM from Baseline to Week 16
11. • Change in EQ-5D-5L from Baseline to Week 16
12. • Absolute and percent change in SD-NRS from Baseline to Week 16
13. •Proportion of participants achieving a 4-point reduction in SD-NRS at Week 16
14. • Change in all efficacy endpoints from Baseline over time
15. • AEs and SAEs, including incidence of clinically significant changes in vital signs, clinical laboratory tests, and ECGs.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aslan Pharmaceuticals Pte Ltd

Sponsor organisation

Aslan Pharmaceuticals Pte Ltd

Address

3 Temasek Avenue

City

Singapore

Postcode

039190

Country

Singapore

Scientific contact point

Organisation

Aslan Pharmaceuticals Pte Ltd

Contact name

ASLAN Pharmaceuticals

Public contact point

Organisation

Aslan Pharmaceuticals Pte Ltd

Contact name

ASLAN Pharmaceuticals

Third parties 8

Locations

2 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications