A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis

NCT04643457 | Completed Phase 1 FDA Drug

• 2 other identifiers: UP00892020-003639-41
• Study Type: interventional
• Target: 107
• Locations: 4 countries
• Sites: 10

Brief Summary

The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB9741 administered by intravenous infusion or subcutaneous injection to healthy study participants and following repeat dosing at a single dose level in study participants with atopic dermatitis. Furthermore, the clinical efficacy outcome in study participants with atopic dermatitis after administration of UCB9741 by intravenous infusion will be investigated.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Healthy Participants; UCB9741

Outcome Measures

Primary Outcomes (5)

• Incidents of treatment-emergent adverse events (TEAEs) during Part A

  An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  From Baseline up to the End of Study Visit (Week 12)

• Incidents of treatment-emergent serious adverse events (TESAEs) during 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 the End of Study Visit (Week 12)

• Incidents of TEAEs during Part B

  An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  From Baseline up to the End of Study Visit (Week 18)

• Incidents of TESAEs during 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 the End of Study Visit (Week 18)

• ≥75% improvement vs Baseline in Eczema Area and Severity Index (EASI75) score during 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.

  Baseline, Week 12

Secondary Outcomes (11)

• Cmax from Baseline through the End of Study (EoT) Visit of Part A

  From Baseline through the End Of Study Visit (Week 12)

• Tmax from Baseline through the End of Study (EoT) Visit of Part A

  From Baseline through the End of Study Visit (Week 12)

• AUC(0-t) from Baseline through the End of Study (EoT) Visit of Part A

  From Baseline through the End of Study Visit (Week 12)

• AUC from Baseline through the End of Study (EoT) Visit of Part A

  From Baseline through the End of Study Visit (Week 12)

• F% from Baseline through the End of Study (EoT) Visit of Part A

  From Baseline through the End of Study Visit (Week 12)

Study Arms (11)

Part A: Intravenous UCB9741 arm 1

EXPERIMENTAL

Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741.

Drug: UCB9741

Part A: Intravenous UCB9741 arm 2

EXPERIMENTAL

Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741.

Drug: UCB9741

Part A: Intravenous UCB9741 arm 3

EXPERIMENTAL

Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741.

Drug: UCB9741

Part A: Intravenous UCB9741 arm 4

EXPERIMENTAL

Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741.

Drug: UCB9741

Part A: Intravenous UCB9741 arm 5

EXPERIMENTAL

Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741.

Drug: UCB9741

Part A: Subcutaneous UCB9741 arm 1

EXPERIMENTAL

Subjects randomized to this arm will receive a pre-specified single subcutaneous dose of UCB9741.

Drug: UCB9741

Part A: Subcutaneous UCB9741 arm 2

EXPERIMENTAL

Subjects randomized to this arm will receive a pre-specified single subcutaneous dose of UCB9741.

Drug: UCB9741

Part A: Intravenous Placebo arm

PLACEBO COMPARATOR

Subjects randomized to this arm will receive intravenous Placebo to maintain the blinding.

Drug: Intravenous Placebo

Part A: Subcutaneous Placebo arm

PLACEBO COMPARATOR

Subjects randomized to this arm will receive subcutaneous Placebo to maintain the blinding.

Drug: Subcutaneous Placebo

Part B: Intravenous UCB9741 arm

EXPERIMENTAL

Subjects randomized to this arm will receive pre-specified intravenous doses of UCB9741.

Drug: UCB9741

Part B: Intravenous Placebo arm

PLACEBO COMPARATOR

Subjects randomized to this arm will receive intravenous Placebo to maintain the blinding.

Drug: Intravenous Placebo

Interventions

UCB9741 DRUG

\- Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.

Part A: Intravenous UCB9741 arm 1; Part A: Intravenous UCB9741 arm 2; Part A: Intravenous UCB9741 arm 3; Part A: Intravenous UCB9741 arm 4; Part A: Intravenous UCB9741 arm 5; Part A: Subcutaneous UCB9741 arm 1; Part A: Subcutaneous UCB9741 arm 2; Part B: Intravenous UCB9741 arm

Intravenous Placebo DRUG

\- Pharmaceutical form: Solution Participants will receive Placebo to maintain the blinding during the Treatment Period.

Part A: Intravenous Placebo arm; Part B: Intravenous Placebo arm

Subcutaneous Placebo DRUG

Pharmaceutical form: Solution Participants will receive subcutaneous Placebo to maintain the blinding during the Treatment Period.

Part A: Subcutaneous Placebo arm

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:
• 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/m\^2 (inclusive)
• Participant can be male or female
• A male participant must agree to use contraception during the Treatment Period and for at least 90 days after the final dose of investigational medicinal product (IMP), and refrain from donating sperm during this period
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 90 days after the final dose of IMP
• Part B:
• Participant must be 18 to 65 years of age inclusive at the time of signing the ICF
• Participant has a documented history of moderate or severe atopic dermatitis (AtD) that has been present for at least 12 months prior to initiating the study (signing of the ICF) and with:
• validated Investigator Global Assessment (vIGA) score ≥3 at Screening (Visit 1) and Baseline (Visit 2)
• Eczema Area and Severity Index (EASI) score of ≥14 at Screening (Visit 1) and ≥16 at Baseline (Visit 2)
• Pruritus Numerical Rating Scale (NRS) score ≥ 3 at Screening (Visit 1) and Baseline (Visit 2)
• ≥10% body surface area (BSA) of AtD involvement at Screening (Visit 1) and Baseline (Visit 2)

You may not qualify if:

• Part A:
• Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or other biologic drugs as stated in this protocol
• Participant has a significant allergy to humanized monoclonal antibodies (mAbs)
• Participant has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions
• Participant has abnormal blood pressure (BP) (outside the normal range) in a supine position after 5 minutes rest
• Participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \>1.0x upper limit of normal (ULN)
• Participant has a recent history or currently active clinically-significant bacterial, fungal, endoparasite, or viral (including hospitalization for coronavirus disease 2019 (COVID-19)) infection (within 6 months of the Screening Visit)
• Participant has a history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)
• Participant has a history of diabetes
• Participant has a corrected QT interval (QTc) \>450 msec
• 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, implants, or intrauterine devices) or occasional use of analgesics, such as paracetamol (acetaminophen, with or without caffeine, with a maximal dose of 4 g/day and 10 g/14 days)
• Participant has received Bacillus Calmette-Guerin vaccinations within 1 year prior to the Baseline Visit or within 90 days after the final dose of IMP
• Participant has been treated with biologic agents (such as mAbs, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to the Baseline Visit
• Participant has participated in another study of an IMP within the previous 90 days or 5 half-lives of the IMP (whichever longer), or is currently participating in another study of an IMP
• Participant has sensitivity to heparin or heparin-induced thrombocytopenia

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (10)

Up0089 303

Pleven, Bulgaria

Location

Up0089 301

Sofia, Bulgaria

Location

Up0089 304

Sofia, Bulgaria

Location

Up0089 407

Berlin, Germany

Location

Up0089 408

Heidelberg, Germany

Location

Up0089 410

Leipzig, Germany

Location

Up0089 201

Leiden, Netherlands

Location

Up0089 104

Liverpool, United Kingdom

Location

Up0089 101

London, United Kingdom

Location

Up0089 103

Manchester, United Kingdom

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: November 19, 2020
• First Posted: November 25, 2020
• Study Start: November 27, 2020
• Primary Completion: April 23, 2024
• Study Completion: June 6, 2024
• Last Updated: September 30, 2025

Record last verified: 2025-09

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

BU (3); DE (3); NL (1); GB (3)