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 Dermatitis (Part B)

NCT05277571 | Completed Phase 1 FDA Drug

• 1 other identifier: UP0110
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Phase 1/2A; Healthy study participants; Patients; UCB1381

Outcome Measures

Primary Outcomes (5)

• Incidents of treatment-emergent adverse events (TEAEs) from Baseline through the End of Study (EOS) Visit (Week 12) in Part A

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.

  From Baseline up to Week 12 in Part A

• Incidents of treatment-emergent serious adverse events (TESAEs) from Baseline through the EOS Visit (Week 12) in Part A

  A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

  From Baseline up to Week 12 in Part A

• Incidents of TEAEs from Baseline through the EOS Visit (Week 22) in Part B

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.

  From Baseline up to Week 22 in Part B

• Incidents of TESAEs from Baseline through the EOS Visit (Week 22) in Part B

  A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

  From Baseline up to Week 22 in Part B

• ≥75% improvement vs Baseline (Yes/No) in Eczema Area and Severity Index score (EASI75) at Week 12 in Part B

  The Eczema Area and Severity Index (EASI) is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. A participant's EASI is scored through evaluation of 4 body regions: Head and neck; Trunk; Upper extremities; Lower extremities The severity of disease is evaluated by assessing each of 4 clinical signs for each area: Erythema; Edema/papulation; Excoriation; Lichenification The severity of each clinical sign is scored as: 0=None, 1=Mild, 2=Moderate, 3=Severe.

  From Baseline up to Week 12 in Part B

Secondary Outcomes (12)

• UCB1381 Cmax from Baseline through the EOS Visit (Week 12) in Part A

  From Baseline up to Week 12 in Part A

• UCB1381 Tmax from Baseline through the EOS Visit (Week 12) in Part A

  From Baseline up to Week 12 in Part A

• UCB1381 AUC(0-t) from Baseline through the EOS Visit (Week 12) in Part A

  From Baseline up to Week 12 in Part A

• UCB1381 AUC from Baseline through the EOS Visit (Week 12) in Part A

  From Baseline up to Week 12 in Part A

• UCB1381 F% from Baseline through the EOS Visit (Week 12) in Part A

  From Baseline up to Week 12 in Part A

Study Arms (12)

UCB1381 dosing regime 1 in Part A

EXPERIMENTAL

Participants will be randomized to receive a single dose UCB1381 intravenously (iv).

Biological: UCB1381

UCB1381 dosing regime 2 in Part A

EXPERIMENTAL

Participants will be randomized to receive a single dose UCB1381 intravenously (iv).

Biological: UCB1381

UCB1381 dosing regime 3 in Part A

EXPERIMENTAL

Participants will be randomized to receive a single dose UCB1381 intravenously (iv).

Biological: UCB1381

UCB1381 dosing regime 4 in Part A

EXPERIMENTAL

Participants will be randomized to receive a single dose UCB1381 intravenously (iv).

Biological: UCB1381

UCB1381 dosing regime 5 in Part A

EXPERIMENTAL

Participants will be randomized to receive a single dose UCB1381 subcutaneously (sc).

Biological: UCB1381

UCB1381 dosing regime 6 in Part A

EXPERIMENTAL

Participants will be randomized to receive a single dose UCB1381 subcutaneously (sc).

Biological: UCB1381

UCB1381 dosing regime 7 in Part A

EXPERIMENTAL

Participants will be randomized to receive a single dose UCB1381 intravenously (iv).

Biological: UCB1381

UCB1381 dosing regime 8 in Part A

EXPERIMENTAL

Participants will be randomized to receive a single dose UCB1381 intravenously (iv).

Biological: UCB1381

UCB1381 dosing regime 9 in Part B

EXPERIMENTAL

Participants will be randomized to receive repeated doses UCB1381 intravenously (iv).

Biological: UCB1381

Placebo iv Arm Part A

PLACEBO COMPARATOR

Participants will be randomized to receive a single dose of placebo iv to maintain the blinding.

Drug: Placebo

Placebo sc Arm Part A

PLACEBO COMPARATOR

Participants will be randomized to receive a single dose of placebo sc to maintain the blinding.

Drug: Placebo

Placebo iv Arm Part B

PLACEBO COMPARATOR

Participants will be randomized to receive repeated doses of placebo iv to maintain the blinding.

Drug: Placebo

Interventions

UCB1381 BIOLOGICAL

UCB1381 will be administered intravenously (iv) or subcutaneously (sc) in different dosages in Part A and iv in Part B

UCB1381 dosing regime 1 in Part A; UCB1381 dosing regime 2 in Part A; UCB1381 dosing regime 3 in Part A; UCB1381 dosing regime 4 in Part A; UCB1381 dosing regime 5 in Part A; UCB1381 dosing regime 6 in Part A; UCB1381 dosing regime 7 in Part A; UCB1381 dosing regime 8 in Part A; UCB1381 dosing regime 9 in Part B

Placebo DRUG

Placebo will be administered iv or sc in Part A and iv in Part B to maintain the blinding.

Placebo iv Arm Part A; Placebo iv Arm Part B; Placebo sc Arm Part A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 30 kg/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
• Either 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 confirmed to be otherwise medically inadvisable (eg, because of important side effects or safety risks)
• Participant has a BMI within the range 18 to 35 kg/m2 (inclusive)

You may not qualify if:

• 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 30 days prior to Screening or 5 half-lives (whichever is longer), if this information can be validated by the investigator
• 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 for AtD (including mild topical 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 for 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 previously used a biologic that affects IL-13 or IL-22 pathways, or any JAK inhibitor (including marketed and/or experimental treatments), within 30 days or 5 half-lives (whichever is longer) of the Baseline Visit. Previous use of biologics affecting IL-13 or IL-22 pathways 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 Development Physician should be consulted
• Participant has previously been randomized in this study

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (16)

Up0110 125

Beverly Hills, California, 90212, United States

Location

Up0110 101

Glendale, California, 91206, United States

Location

Up0110 116

Los Angeles, California, 90045, United States

Location

Up0110 121

Northridge, California, 91324, United States

Location

Up0110 126

Tustin, California, 92780, United States

Location

Up0110 127

Valencia, California, 91355, United States

Location

Up0110 108

Clearwater, Florida, 33765, United States

Location

Up0110 109

Miami Lakes, Florida, 33014, United States

Location

Up0110 106

Ocala, Florida, 34471, United States

Location

Up0110 102

St. Petersburg, Florida, 33705, United States

Location

Up0110 111

College Park, Georgia, 30349, United States

Location

Up0110 114

Minneapolis, Minnesota, 55455, United States

Location

Up0110 107

New York, New York, 10029, United States

Location

Up0110 124

Winston-Salem, North Carolina, 27103, United States

Location

Up0110 104

Oklahoma City, Oklahoma, 73170, United States

Location

Up0110 119

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: March 7, 2022
• Primary Completion: July 17, 2025
• Study Completion: September 19, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Locations

US (16)