Clinical trial
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
Name
AK120-102
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 the treatment of subjects with moderate to severe atopic dermatitis.
Trial arms
Trial start
2021-11-03
Estimated PCD
2024-09-30
Trial end
2024-10-30
Status
Recruiting
Phase
Early phase I
Treatment
AK120
subcutaneous injection once a week
Arms:
AK120 150 mg in phase Ib
AK120
subcutaneous injection once a week
Arms:
AK120 300mg in phase Ib
Placebo
subcutaneous injection once a week.
Arms:
Placebo Comparator: Placebo in phase Ib
AK120
subcutaneous injection every 2 weeks.
Arms:
AK120 150mg in phase II
AK120
subcutaneous injection every 2 weeks.
Arms:
AK120 300mg in phase II
AK120
subcutaneous injection every 2 weeks.
Arms:
AK120 450mg in phase II
Placebo
subcutaneous injection every 2 weeks for 16 weeks then crossover to AK120 Regimen 4 and Regimen 5.
Arms:
Placebo Comparator: Placebo in phase II
AK120
subcutaneous injection every 2 weeks
Arms:
AK120 150mg in phase II extension
AK120
subcutaneous injection every 2 weeks.
Arms:
AK120 300mg in phase II extension
AK120
subcutaneous injection every 2 weeks.
Arms:
AK120 450mg in phase II extension
Size
416
Primary endpoint
Phase Ib
Baseline to week 12
Phase Ib
Baseline to week 12
Phase Ib
Baseline to week 12
Phase Ib
Baseline to week 12
Phase Ib
Baseline to week 12
Phase II
at week 16
Phase II Extension Study
Baseline to week 24
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 416, 'type': 'ESTIMATED'}}
Updated at
2023-09-13
1 organization
2 products
1 indication
Organization
AkesoProduct
AK120Indication
Atopic DermatitisProduct
Placebo