A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis

Akeso

Status and phase: Completed; Phase 2; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: AK120; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06035354

AK120-102

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.

Full description

This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in subjects with moderate to severe atopic dermatitis.

Enrollment: 427 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female with age 18 - 75 years (inclusive).
2. Atopic dermatitis (AD) diagnosed at least half an year before screening.
3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.

Exclusion criteria

1. Suffering from other inflammatory diseases that may affect efficacy outcomes (such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.).
2. History of exposure to active TB, and/or history or current evidence of TB infection.
3. Positive serology results at Screening for hepatitis B, hepatitis C or HIV.
4. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.
5. History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit
6. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with participation in the study, or interfere with the interpretation of study results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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427 participants in 10 patient groups, including a placebo group

AK120 150 mg in phase Ib

Experimental group

Description:

subcutaneous injection once a week for 4 weeks.

Treatment:

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

AK120 300mg in phase Ib

Experimental group

Description:

subcutaneous injection once a week for 4 weeks.

Treatment:

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Placebo Comparator: Placebo in phase Ib

Placebo Comparator group

Description:

subcutaneous injection once a week for 4 weeks.

Treatment:

Drug: Placebo

Drug: Placebo

AK120 150mg in phase II

Experimental group

Description:

subcutaneous injection every 2 weeks for 50 weeks.

Treatment:

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

AK120 300mg in phase II

Experimental group

Description:

subcutaneous injection every 2 weeks for 50 weeks.

Treatment:

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

AK120 450mg in phase II

Experimental group

Description:

subcutaneous injection every 2 weeks for 50 weeks.

Treatment:

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Placebo Comparator: Placebo in phase II

Placebo Comparator group

Description:

subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 4 and Regimen 5, subcutaneous injection at week 16, after primary endpoint evaluation.

Treatment:

Drug: Placebo

Drug: Placebo

AK120 150mg in phase II extension

Experimental group

Description:

subcutaneous injection every 2 weeks for 14 weeks.

Treatment:

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

AK120 300mg in phase II extension

Experimental group

Description:

subcutaneous injection every 2 weeks for 14 weeks.

Treatment:

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

AK120 450mg in phase II extension

Experimental group

Description:

subcutaneous injection every 2 weeks for 14 weeks.

Treatment:

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120

Drug: AK120