EBLASAKIMAB for Atopic dermatitis

Inclusion criteria

• {"criterion_text":"- 1.\tMale or female participants ≥18 years old;\n- 2.\tWilling and able to comply with clinic visits and study-related procedures;\n- 3.\tChronic AD present for at least 1 year prior to the Screening visit;\n- 4.\tHave a vIGA score of ≥3 (5-point scale, 0-4) at the Baseline;\n- 5.\tHave ≥10% BSA of AD involvement at the Baseline;\n- 6.\tHave an EASI score ≥18 at the Screening and Baseline visits.\n- 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\n- 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

• {"criterion_text":"- 1.\tUse of immunosuppressive/immunomodulating drugs and/or therapies, JAK inhibitors, or phototherapy (including tanning booth/parlor) within 4 weeks prior to the Baseline visit;\n- 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\n- 11. Allergen immunotherapy should be discontinued 6 months before randomization\n- 2.\tHave an uncontrolled chronic disease that may require multiple intermittent use of systemic corticosteroids at Screening, as defined by the Investigator;\n- 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;\n- 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\n- 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\n- 6. Have inadequate organ function or abnormal lab results considered clinically significant by the Investigator at the Screening visit\n- 7. History of human immunodeficiency virus (HIV) or positive HIV serology at Screening\n- 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.\n- 9. Have known liver cirrhosis and/or chronic hepatitis of any etiology"}

Primary endpoints

• {"endpoint_text":"- Percentage change in EASI score from Baseline to Week 16","definition_or_measurement_approach":"Eczema Area and Severity Index (EASI): percentage change from Baseline to Week 16"}

Secondary endpoints

• {"endpoint_text":"- • Proportion of participants achieving vIGA response of 0 (clear) or 1 (almost clear) [5-point scale] at Week 16\n- • Proportion of participants with a 75% reduction from Baseline in EASI (EASI 75) at Week 16\n- • Proportion of participants achieving EASI 50 and EASI 90 at Week 16\n- • Proportion of participants with EASI <7 at Week 16\n- • Absolute and percent change in peak P-NRS from Baseline to Week 16\n- • Proportion of participants achieving a 4-point reduction in peak PNRS at Week 16\n- • Change in BSA affected with AD from Baseline to Week 16\n- • Change in SCORAD from Baseline to Week 16\n- • Change in DLQI from Baseline to Week 16\n- • Change in POEM from Baseline to Week 16\n- • Change in EQ-5D-5L from Baseline to Week 16\n- • Absolute and percent change in SD-NRS from Baseline to Week 16\n- •Proportion of participants achieving a 4-point reduction in SD-NRS at Week 16\n- • Change in all efficacy endpoints from Baseline over time\n- • AEs and SAEs, including incidence of clinically significant changes in vital signs, clinical laboratory tests, and ECGs.","definition_or_measurement_approach":"vIGA: validated Investigator Global Assessment (vIGA) 5-point scale at Week 16; EASI 75/50/90: percent reductions in EASI from Baseline at Week 16; P-NRS: peak Pruritus Numerical Rating Scale absolute and percent change and ≥4-point reduction; BSA: change in Body Surface Area affected by AD; SCORAD: change from Baseline to Week 16; DLQI, POEM, EQ-5D-5L: change from Baseline to Week 16 using respective validated instruments; SD-NRS: Sleep Disturbance NRS absolute/percent change and ≥4-point reduction; safety endpoints: reporting of AEs and SAEs, vital signs, labs, and ECGs."}

Germany

Earliest CTIS Part Ii Submission Date

25-03-2024

Latest Decision Or Authorization Date

31-05-2024

Processing Time Days

67

Number Of Sites

4

Number Of Participants

25

Poland

Earliest CTIS Part Ii Submission Date

06-05-2024

Latest Decision Or Authorization Date

31-05-2024

Processing Time Days

25

Number Of Sites

7

Number Of Participants

25

Primary sponsor

Full Name

Aslan Pharmaceuticals Pte Ltd

Organisation Type

Pharmaceutical company

Country Of Registered Address

Singapore

Contract research organisations

Name

Syneos Health Netherlands B.V.

Name

Sonic Clinical Trials Pty Limited

Name

Pharmaceutical Product Development LLC

Name

Agilex Biolabs Pty Limited

Responsibilities

sample management

Third parties

• {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Australia","full_name":"Sonic Clinical Trials Pty Limited","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Photography","organisation_type":"Pharmaceutical company"}
• {"country":"Australia","full_name":"Agilex Biolabs Pty Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Datacubed Health Inc.","duties_or_roles":"ePRO","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Equipment","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"translations","organisation_type":"Pharmaceutical company"}