Atopic DermatitisPhase 1/2NCT05277571
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)
A Phase 1/2 study testing UCB1381 in people with Atopic Dermatitis, run by UCB Biopharma SRL at 16 sites in United States.
Trial 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. 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?
- UCB1381
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 16 sitesUnited States
- Study dates
- 7 Mar 2022to 19 Sep 2025
- 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 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)
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- 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)
Who cannot join
- 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
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- 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
- Participant has participated in previous studies with 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 participated in another study of an IMP within 30 days or 5 half-lives (whichever is longer) of the Baseline Visit or is currently participating in another study of an IMP
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Up0110 125
Beverly Hills, California, 90212
Up0110 108
Clearwater, Florida, 33765
Up0110 111
College Park, Georgia, 30349
Up0110 101
Glendale, California, 91206
Up0110 116
Los Angeles, California, 90045
Up0110 109
Miami Lakes, Florida, 33014
Up0110 114
Minneapolis, Minnesota, 55455
Up0110 107
New York, New York, 10029
Up0110 121
Northridge, California, 91324
Up0110 106
Ocala, Florida, 34471
Up0110 104
Oklahoma City, Oklahoma, 73170
Up0110 119
Philadelphia, Pennsylvania, 19103
Up0110 102
St. Petersburg, Florida, 33705
Up0110 126
Tustin, California, 92780
Up0110 127
Valencia, California, 91355
Up0110 124
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 1/2A, Randomized, Placebo-Controlled, Single-Ascending Dose (Part A, Participant- and Investigator-Blind) and Repeat-Dose (Part B, Participant-, Investigator-, and Sponsor-Blind) 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)
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
- Being tested
- UCB1381, Placebo
- Keywords
- Atopic dermatitis, Phase 1/2A, Healthy study participants, Patients, UCB1381
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB1381Biological
UCB1381 will be administered intravenously (iv) or subcutaneously (sc) in different dosages in Part A and iv in Part B
PlaceboDrug
Placebo will be administered iv or sc in Part A and iv in Part B to maintain the blinding.
| Study group | Role | What they receive |
|---|---|---|
| UCB1381 dosing regime 1 in Part A | Experimental | Participants will be randomized to receive a single dose UCB1381 intravenously (iv). Receives: Biological: UCB1381 |
| UCB1381 dosing regime 2 in Part A | Experimental | Participants will be randomized to receive a single dose UCB1381 intravenously (iv). Receives: Biological: UCB1381 |
| UCB1381 dosing regime 3 in Part A | Experimental | Participants will be randomized to receive a single dose UCB1381 intravenously (iv). Receives: Biological: UCB1381 |
| UCB1381 dosing regime 4 in Part A | Experimental | Participants will be randomized to receive a single dose UCB1381 intravenously (iv). Receives: Biological: UCB1381 |
| UCB1381 dosing regime 5 in Part A | Experimental | Participants will be randomized to receive a single dose UCB1381 subcutaneously (sc). Receives: Biological: UCB1381 |
| UCB1381 dosing regime 6 in Part A | Experimental | Participants will be randomized to receive a single dose UCB1381 subcutaneously (sc). Receives: Biological: UCB1381 |
| UCB1381 dosing regime 7 in Part A | Experimental | Participants will be randomized to receive a single dose UCB1381 intravenously (iv). Receives: Biological: UCB1381 |
| UCB1381 dosing regime 8 in Part A | Experimental | Participants will be randomized to receive a single dose UCB1381 intravenously (iv). Receives: Biological: UCB1381 |
| UCB1381 dosing regime 9 in Part B | Experimental | Participants will be randomized to receive repeated doses UCB1381 intravenously (iv). Receives: 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. Receives: 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. Receives: Drug: Placebo |
| Placebo iv Arm Part B | Placebo comparator | Participants will be randomized to receive repeated doses of placebo iv to maintain the blinding. Receives: Drug: 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) 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Cmax: Maximum observed concentration
Measured: From Baseline up to Week 12 in Part A
UCB1381 Tmax from Baseline through the EOS Visit (Week 12) in Part A
Tmax: Time of observed Cmax
Measured: From Baseline up to Week 12 in Part A
UCB1381 AUC(0-t) from Baseline through the EOS Visit (Week 12) in Part A
AUC(0-t): Area under the concentration-time curve from time zero to the time of last detectable concentration.
Measured: From Baseline up to Week 12 in Part A
UCB1381 AUC from Baseline through the EOS Visit (Week 12) in Part A
AUC: Area under the concentration-time curve from time zero to infinity.
Measured: From Baseline up to Week 12 in Part A
UCB1381 F% from Baseline through the EOS Visit (Week 12) in Part A
F%: Bioavailability of subcutaneous administration
Measured: From Baseline up to Week 12 in Part A
Percent change from Baseline in EASI score 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.
Measured: From Baseline up to Week 12 in Part B
≥50% improvements vs Baseline (Yes/No) in EASI score (EASI50) 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.
Measured: From Baseline up to Week 12 in Part B
≥90% improvements vs Baseline (Y/N) in EASI score (EASI90) 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.
Measured: From Baseline up to Week 12 in Part B
Validated Investigator Global Assessment (vIGA) score of 0 or 1 (Y/N) at Week 12 in Part B
vIGA: Validated Investigator Global Assessment score is using descriptors that best describe the overall appearance of the lesions at a given time point. Assessment: vIGA 0=clear, vIGA 1=almost clear, vIGA 2=mild, vIGA 3=moderate, vIGA 4=severe
Measured: From Baseline up to Week 12 in Part B
UCB1381 Cmax at week 12 after the final dose in Part B
Cmax: Maximum observed concentration
Measured: From Baseline up to Week 12 in Part B
UCB1381 Tmax at week 12 after the final dose in Part B
Tmax: Time of observed Cmax
Measured: From Baseline up to Week 12 in Part B
UCB1381 AUCtau at week 12 after the final dose in Part B
AUCtau: Area under the curve for the dosing interval after the final dose.
Measured: From Baseline up to Week 12 in Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start7 Mar 2022
- Primary completion17 Jul 2025
- Study completion19 Sep 2025
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
- 109 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
- NCT05277571
- Sponsor's protocol ID
- UP0110
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2022
- Last updated
- 22 Jul 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 reidentifying 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2A, Randomized, Placebo-Controlled, Single-Ascending Dose (Part A, Participant- and Investigator-Blind) and Repeat-Dose (Part B, Participant-, Investigator-, and Sponsor-Blind) 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)
- ClinicalTrials.gov ID
- NCT05277571
- Acronym / sponsor ID
- UP0110
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Phase 1/2A, Healthy study participants, Patients, UCB1381
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 14 Mar 2022 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| UCB1381 dosing regime 1 in Part A | Experimental | Biological: UCB1381Participants will be randomized to receive a single dose UCB1381 intravenously (iv). |
| UCB1381 dosing regime 2 in Part A | Experimental | Biological: UCB1381Participants will be randomized to receive a single dose UCB1381 intravenously (iv). |
| UCB1381 dosing regime 3 in Part A | Experimental | Biological: UCB1381Participants will be randomized to receive a single dose UCB1381 intravenously (iv). |
| UCB1381 dosing regime 4 in Part A | Experimental | Biological: UCB1381Participants will be randomized to receive a single dose UCB1381 intravenously (iv). |
| UCB1381 dosing regime 5 in Part A | Experimental | Biological: UCB1381Participants will be randomized to receive a single dose UCB1381 subcutaneously (sc). |
| UCB1381 dosing regime 6 in Part A | Experimental | Biological: UCB1381Participants will be randomized to receive a single dose UCB1381 subcutaneously (sc). |
| UCB1381 dosing regime 7 in Part A | Experimental | Biological: UCB1381Participants will be randomized to receive a single dose UCB1381 intravenously (iv). |
| UCB1381 dosing regime 8 in Part A | Experimental | Biological: UCB1381Participants will be randomized to receive a single dose UCB1381 intravenously (iv). |
| UCB1381 dosing regime 9 in Part B | Experimental | Biological: UCB1381Participants will be randomized to receive repeated doses UCB1381 intravenously (iv). |
| Placebo iv Arm Part A | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive a single dose of placebo iv to maintain the blinding. |
| Placebo sc Arm Part A | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive a single dose of placebo sc to maintain the blinding. |
| Placebo iv Arm Part B | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive repeated doses of placebo iv 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 (14 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| UCB1381UCB1381 will be administered intravenously (iv) or subcutaneously (sc) in different dosages in Part A and iv in Part B | Biological | 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 |
| PlaceboPlacebo will be administered iv or sc in Part A and iv in Part B to maintain the blinding. | Drug | Placebo iv Arm Part A, Placebo iv Arm Part B, Placebo sc Arm Part A |
Primary outcome
Incidents of treatment-emergent adverse events (TEAEs) from Baseline through the End of Study (EOS) Visit (Week 12) in Part A
Time frame: From Baseline up to 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.
Incidents of treatment-emergent serious adverse events (TESAEs) from Baseline through the EOS Visit (Week 12) in Part A
Time frame: From Baseline up to 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
Incidents of TEAEs from Baseline through the EOS Visit (Week 22) in Part B
Time frame: From Baseline up to 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.
Incidents of TESAEs from Baseline through the EOS Visit (Week 22) in Part B
Time frame: From Baseline up to 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
≥75% improvement vs Baseline (Yes/No) in Eczema Area and Severity Index score (EASI75) at Week 12 in Part B
Time frame: From Baseline up to 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.
12 secondary outcomes
UCB1381 Cmax from Baseline through the EOS Visit (Week 12) in Part A
Time frame: From Baseline up to Week 12 in Part A
UCB1381 Tmax from Baseline through the EOS Visit (Week 12) in Part A
Time frame: From Baseline up to Week 12 in Part A
UCB1381 AUC(0-t) from Baseline through the EOS Visit (Week 12) in Part A
Time frame: From Baseline up to Week 12 in Part A
UCB1381 AUC from Baseline through the EOS Visit (Week 12) in Part A
Time frame: From Baseline up to Week 12 in Part A
UCB1381 F% from Baseline through the EOS Visit (Week 12) in Part A
Time frame: From Baseline up to Week 12 in Part A
Percent change from Baseline in EASI score at Week 12 in Part B
Time frame: From Baseline up to Week 12 in Part B
≥50% improvements vs Baseline (Yes/No) in EASI score (EASI50) at Week 12 in Part B
Time frame: From Baseline up to Week 12 in Part B
≥90% improvements vs Baseline (Y/N) in EASI score (EASI90) at Week 12 in Part B
Time frame: From Baseline up to Week 12 in Part B
Validated Investigator Global Assessment (vIGA) score of 0 or 1 (Y/N) at Week 12 in Part B
Time frame: From Baseline up to Week 12 in Part B
UCB1381 Cmax at week 12 after the final dose in Part B
Time frame: From Baseline up to Week 12 in Part B
UCB1381 Tmax at week 12 after the final dose in Part B
Time frame: From Baseline up to Week 12 in Part B
UCB1381 AUCtau at week 12 after the final dose in Part B
Time frame: From Baseline up to Week 12 in Part B
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 22 Jul 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 reidentifying 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)
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UCB1381 in people with Atopic Dermatitis, run by UCB Biopharma SRL at 16 sites in United States.
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 14 inclusion and 17 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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) from Baseline through the End of Study (EOS) Visit (Week 12) in Part A (time frame: From Baseline up to Week 12 in Part A). 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 22 Jul 2026.