Atopic DermatitisPhase 1/2NCT04643457
A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis
A Phase 1/2 study testing UCB9741 in people with Atopic Dermatitis, run by UCB Biopharma SRL at 10 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- UCB9741
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 27 Nov 2020to 6 Jun 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- 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)
- 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). Inadequate response is defined as failure to achieve and maintain remission or low disease remission or a low disease activity state (validated Investigator Global Assessment (vIGA) 0=clear to vIGA 2=mild) despite treatment with a daily regimen of TCS of medium to higher potency (±TCI as appropriate), applied for at least 4 weeks or for the maximum duration recommended by the product prescribing information (eg, 2 weeks for high potency TCS), whichever is shorter
- Participant has a body mass index (BMI) within the range 18 to 32 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 60 days after the final dose of 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:
- 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 60 days after the final dose of IMP
Who cannot join
- 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)
Show all 30Show fewer
- 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
- Part B:
- Participant has a known hypersensitivity to any components of the IMP or other biologic drugs as stated in this protocol
- Participant has significant allergies to humanized mAbs
- Participant has clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
- Participant has abnormal BP (outside the normal range) in a supine position after 5 minutes rest
- Participant has ALT, AST, or ALP >1.5xULN
- Participant has a recent history of or clinically active clinically-significant, as judged by the Investigator, bacterial, fungal, endoparasite, or viral (or any history of hospitalization for 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 that is not well controlled with diet
- Participant has a mean QT interval (QTc) >450 msec for male study participants or >470 msec for female study participants
- 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) or intranasal corticosteroids for seasonal rhinitis or inhaled bronchodilators and low dose inhaled corticosteroids for mild asthma
- Participant has received Bacillus Calmette-Guerin vaccinations within 1 year prior to the Baseline Visit or is anticipated to do so within 60 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 30 days or 5 half-lives of IMP (whichever longer) from the Baseline Visit or is currently participating in another study of an IMP
- Participant has sensitivity to heparin or heparin-induced thrombocytopenia
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United Kingdom3 sites
Up0089 104
Liverpool
Up0089 101
London
Up0089 103
Manchester
About this study
Official title: A Phase I/IIA, Randomized, Placebo-Controlled, Single-Ascending Dose (Part A, Participant- and Investigator-Blind) and Repeated-Dose (Part B, Participant-, Investigator-, and Sponsor-Blind) Study to Investigate the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants (Part A) and in Study Participants With Moderate-to-Severe Atopic Dermatitis (Part B)
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
- Being tested
- UCB9741, Intravenous Placebo, Subcutaneous Placebo
- Keywords
- Atopic dermatitis, Healthy Participants, UCB9741
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB9741Drug
- Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.
Intravenous PlaceboDrug
- Pharmaceutical form: Solution Participants will receive Placebo to maintain the blinding during the Treatment Period.
Subcutaneous PlaceboDrug
Pharmaceutical form: Solution Participants will receive subcutaneous Placebo to maintain the blinding during the Treatment Period.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Intravenous UCB9741 arm 1 | Experimental | Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741. Receives: Drug: UCB9741 |
| Part A: Intravenous UCB9741 arm 2 | Experimental | Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741. Receives: Drug: UCB9741 |
| Part A: Intravenous UCB9741 arm 3 | Experimental | Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741. Receives: Drug: UCB9741 |
| Part A: Intravenous UCB9741 arm 4 | Experimental | Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741. Receives: Drug: UCB9741 |
| Part A: Intravenous UCB9741 arm 5 | Experimental | Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741. Receives: Drug: UCB9741 |
| Part A: Subcutaneous UCB9741 arm 1 | Experimental | Subjects randomized to this arm will receive a pre-specified single subcutaneous dose of UCB9741. Receives: Drug: UCB9741 |
| Part A: Subcutaneous UCB9741 arm 2 | Experimental | Subjects randomized to this arm will receive a pre-specified single subcutaneous dose of UCB9741. Receives: Drug: UCB9741 |
| Part A: Intravenous Placebo arm | Placebo comparator | Subjects randomized to this arm will receive intravenous Placebo to maintain the blinding. Receives: Drug: Intravenous Placebo |
| Part A: Subcutaneous Placebo arm | Placebo comparator | Subjects randomized to this arm will receive subcutaneous Placebo to maintain the blinding. Receives: Drug: Subcutaneous Placebo |
| Part B: Intravenous UCB9741 arm | Experimental | Subjects randomized to this arm will receive pre-specified intravenous doses of UCB9741. Receives: Drug: UCB9741 |
| Part B: Intravenous Placebo arm | Placebo comparator | Subjects randomized to this arm will receive intravenous Placebo to maintain the blinding. Receives: Drug: Intravenous Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, Week 12
Secondary outcomes (11)
Cmax from Baseline through the End of Study (EoT) Visit of Part A
Cmax: Maximum observed serum concentration
Measured: From Baseline through the End Of Study Visit (Week 12)
Tmax from Baseline through the End of Study (EoT) Visit of Part A
tmax: Time to maximum observed serum concentration
Measured: 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
AUC(0-t): Area under the serum concentration-time curve from time zero to time t
Measured: From Baseline through the End of Study Visit (Week 12)
AUC from Baseline through the End of Study (EoT) Visit of Part A
AUC: Area under the serum concentration-time curve from time 0 to last observed quantifiable concentration
Measured: From Baseline through the End of Study Visit (Week 12)
F% from Baseline through the End of Study (EoT) Visit of Part A
F%= Bioavailability of subcutaneous route
Measured: From Baseline through the End of Study Visit (Week 12)
Percent change from Baseline in the Eczema Area and Severity Index (EASI) score at Week 12 of 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.
Measured: Baseline, Week 12
≥50% improvement vs Baseline in EASI score (EASI50) at Week 12 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.
Measured: Baseline, Week 12
≥90% improvement vs Baseline in EASI score (EASI90) at Week 12 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.
Measured: Baseline, Week 12
Cmax after the final dose of Part B
Cmax: Maximum observed serum concentration
Measured: Week 12
Tmax after the final dose of Part B
tmax: Time to maximum observed serum concentration
Measured: Week 12
AUCtau at Week 12 of Part B
AUCtau: Area under the curve for the dosing interval after the final dose
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start27 Nov 2020
- Primary completion23 Apr 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643457
- Sponsor's protocol ID
- UP0089
- Other IDs
- 2020-003639-41
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2020
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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 prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIA, Randomized, Placebo-Controlled, Single-Ascending Dose (Part A, Participant- and Investigator-Blind) and Repeated-Dose (Part B, Participant-, Investigator-, and Sponsor-Blind) Study to Investigate the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants (Part A) and in Study Participants With Moderate-to-Severe Atopic Dermatitis (Part B)
- ClinicalTrials.gov ID
- NCT04643457
- Acronym / sponsor ID
- UP0089
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Healthy Participants, UCB9741
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part A: Intravenous UCB9741 arm 1 | Experimental | Drug: UCB9741Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741. |
| Part A: Intravenous UCB9741 arm 2 | Experimental | Drug: UCB9741Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741. |
| Part A: Intravenous UCB9741 arm 3 | Experimental | Drug: UCB9741Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741. |
| Part A: Intravenous UCB9741 arm 4 | Experimental | Drug: UCB9741Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741. |
| Part A: Intravenous UCB9741 arm 5 | Experimental | Drug: UCB9741Subjects randomized to this arm will receive a pre-specified single intravenous dose of UCB9741. |
| Part A: Subcutaneous UCB9741 arm 1 | Experimental | Drug: UCB9741Subjects randomized to this arm will receive a pre-specified single subcutaneous dose of UCB9741. |
| Part A: Subcutaneous UCB9741 arm 2 | Experimental | Drug: UCB9741Subjects randomized to this arm will receive a pre-specified single subcutaneous dose of UCB9741. |
| Part A: Intravenous Placebo arm | Placebo comparator | Drug: Intravenous PlaceboSubjects randomized to this arm will receive intravenous Placebo to maintain the blinding. |
| Part A: Subcutaneous Placebo arm | Placebo comparator | Drug: Subcutaneous PlaceboSubjects randomized to this arm will receive subcutaneous Placebo to maintain the blinding. |
| Part B: Intravenous UCB9741 arm | Experimental | Drug: UCB9741Subjects randomized to this arm will receive pre-specified intravenous doses of UCB9741. |
| Part B: Intravenous Placebo arm | Placebo comparator | Drug: Intravenous PlaceboSubjects randomized to this arm will receive intravenous Placebo to maintain the blinding. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
- Participant must be 18 to 65 years of age inclusive at the time of signing the ICF
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCB9741- Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period. | Drug | 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- Pharmaceutical form: Solution Participants will receive Placebo to maintain the blinding during the Treatment Period. | Drug | Part A: Intravenous Placebo arm, Part B: Intravenous Placebo arm |
| Subcutaneous PlaceboPharmaceutical form: Solution Participants will receive subcutaneous Placebo to maintain the blinding during the Treatment Period. | Drug | Part A: Subcutaneous Placebo arm |
Primary outcome
Incidents of treatment-emergent adverse events (TEAEs) during Part A
Time frame: From Baseline up to the End of Study Visit (Week 12)
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.
Incidents of treatment-emergent serious adverse events (TESAEs) during Part A
Time frame: From Baseline up to the End of Study Visit (Week 12)
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
Incidents of TEAEs during Part B
Time frame: From Baseline up to the End of Study Visit (Week 18)
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.
Incidents of TESAEs during Part B
Time frame: From Baseline up to the End of Study Visit (Week 18)
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
≥75% improvement vs Baseline in Eczema Area and Severity Index (EASI75) score during Part B
Time frame: Baseline, Week 12
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.
11 secondary outcomes
Cmax from Baseline through the End of Study (EoT) Visit of Part A
Time frame: From Baseline through the End Of Study Visit (Week 12)
Tmax from Baseline through the End of Study (EoT) Visit of Part A
Time frame: 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
Time frame: From Baseline through the End of Study Visit (Week 12)
AUC from Baseline through the End of Study (EoT) Visit of Part A
Time frame: From Baseline through the End of Study Visit (Week 12)
F% from Baseline through the End of Study (EoT) Visit of Part A
Time frame: From Baseline through the End of Study Visit (Week 12)
Percent change from Baseline in the Eczema Area and Severity Index (EASI) score at Week 12 of Part B
Time frame: Baseline, Week 12
≥50% improvement vs Baseline in EASI score (EASI50) at Week 12 during Part B
Time frame: Baseline, Week 12
≥90% improvement vs Baseline in EASI score (EASI90) at Week 12 during Part B
Time frame: Baseline, Week 12
Cmax after the final dose of Part B
Time frame: Week 12
Tmax after the final dose of Part B
Time frame: Week 12
AUCtau at Week 12 of Part B
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Yes. 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. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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 prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UCB9741 in people with Atopic Dermatitis, run by UCB Biopharma SRL at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Bulgaria, Germany, United Kingdom, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidents of treatment-emergent adverse events (TEAEs) during Part A (time frame: From Baseline up to the End of Study Visit (Week 12)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.