A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermati

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants with atopic dermatitis. Efficacy will be assessed following repeat intravenous dosing versus placebo in study participants with atopic dermatitis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UCB Biopharma SRL

Criteria

Inclusion criteria Part A - Healthy study participants

• Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)

• Participant must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring

• Participant has a body mass index (BMI) within the range 18 to 30kg/m2 (inclusive)

• Participant can be male or female and must agree to use contraception

Part B - Participants with moderate to severe Atopic dermatitis (AtD) -Participant must be 18 to 65 years of age inclusive at the time of signing the ICF

Participant has moderate or severe AtD that has been present for at least 12 months prior to initiating the study (signing of the ICF) and with:

• A validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline

• An Eczema Area and Severity Index (EASI) score of ≥14 at Screening and ≥16 at Baseline

• Pruritis Numerical Rating Scale (NRS) ≥3 at Screening and Baseline

-≥10 % body surface area (BSA) of AtD involvement at Screening and Baseline

• Documented recent history (within 6 months before the Screening Visit) of inadequate response to treatment with topical medications (regular use of topical corticosteroids [TCS] or topical calcineurin inhibitors [TCIs]) or when topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks)

Exclusion criteria Part A - Healthy study participants

• Participant has a history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, electrocardiogram (ECG), or vital sign that, in the opinion of the investigator, could significantly alter the absorption, metabolism, or elimination of drugs; constitute a risk when taking the study intervention; or interfere with the interpretation of data

• Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or other biologic drugs (including humanized monoclonal antibodies (mAbs)), clinically significant drug allergies, or history of severe adverse reactions after drug administration

• Participant has a past history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)

• Participant has previously been randomized in this study

• Participant has participated in another study of an IMP or has received any biologic agent (such as mAbs, including marketed drugs and including biologic agents that target interleukin (IL)-13 or IL-22) within the 90 days prior to Screening or 5 half lives (whichever is longer)

Part B - Participants with moderate to severe AtD

• Participant has a history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, electrocardiogram (ECG), or vital sign that, in the opinion of the investigator, could significantly alter the absorption, metabolism, or elimination of drugs; constitute a risk when taking the study intervention; or interfere with the interpretation of data

• Participant has a known hypersensitivity to any components of the IMP or other biologic drugs (including humanized mAbs), clinically significant drug allergies, or history of severe adverse reactions after drug administration

• Participant has a past history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)

• Participant has had pharmaceutically active topical therapies affecting AtD (including mild pical corticosteroids (TCS)) within 2 weeks of the Baseline Visit (corticosteroids, cyclosporin or other calcineurin inhibitors [eg, tacrolimus, pimecrolimus])

• Participant has received phototherapy or systemic non-biologic therapies affecting AtD within 4 weeks of the Baseline Visit (including moderate/strong corticosteroids, cyclosporine A or other calcineurin inhibitors, mycophenolate mofetil, azathioprine, methotrexate, or any alternative medicine for AtD, eg, traditional Chinese medicine)

• Participant has received treatment with dupilumab within 90 days of the Baseline Visit. Previous use of dupilumab is only accepted if treatment was stopped due to reasons other than inadequate efficacy and safety (eg, administrative reasons, poor convenience, poor access to drug)

• Participant has received any prescription or nonprescription medicines, including over the counter remedies and herbal and dietary supplements (other than vitamins within recommended daily dose limits) within 14 days (or 5 half-lives of the respective drug, whichever is longer) prior to the Baseline Visit, other than contraceptives (oral, implant, or intrauterine devices) or occasional use of analgesics such as paracetamol (acetaminophen, with or without caffeine, with a maximal dose of 4g/day and 10g/14 days) or intranasal corticosteroids for seasonal rhinitis or inhaled bronchodilators and low dose inhaled corticosteroids for mild asthma. In case of uncertainty, the UCB Study Physician should be consulted

• Participant has previously been randomized in this study

• Participant has participated in previous studies with dupilumab, any treatment that targets IL-13 or IL-22, or any janus kinase (JAK) inhibitor (including marketed and/or experimental treatments), within 90 days or 5 half-lives (whichever is longer) of the Baseline Visit. Previous use of any of these treatments is only accepted if treatment was stopped due to reasons other than inadequate efficacy and safety (eg, administrative reasons, poor convenience, poor access to drug)

• Participant has participated in previous studies with any experimental anti-IL 22 or anti IL 13 compound, if this information can be validated by the investigator

• Participant has participated in another study of an IMP within 90 days or 5 half-lives (whichever is longer) of the Baseline Visit or is currently participating in another study of an IMP