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Atopic DermatitisPhase 2PossibILityNCT07277660

A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis

A Phase 2 study testing Galvokimig in people with Atopic Dermatitis, run by UCB Biopharma SRL at 59 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of the study is to evaluate the dose-response relationship of galvokimig compared with placebo in study participants with moderate-to-severe atopic dermatitis (AtD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Galvokimig
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
59 sitesin 9 countries
Study dates
29 Dec 2025to 6 Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be aged greater than or equal (≥)18 years at the time of signing the informed consent
  • Participant has chronic atopic dermatitis (AtD) (according to American Academy of Dermatology Consensus Criteria) that has been present for at least ≥1 year prior to initiating the study (ie, signing of the informed consent form [ICF]) and with:
  • validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline
  • Eczema Area and Severity Index (EASI) score ≥16 at both Screening and Baseline
  • Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥4 at both Screening and Baseline
  • ≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline
  • Documented recent history (within 6 months prior to Screening) of inadequate response to treatment with topical medications, or study participants for whom topical treatments are otherwise medically inadvisable (eg, due to important side effects or safety risks) and who are candidates for systemic therapy

Who cannot join

  • Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study
  • Active dermatologic conditions that may confound the diagnosis of AtD or would interfere with assessment of treatment, such as but not limited to scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, active allergic or irritant contact dermatitis
  • Presence or family history (first degree) of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)
  • History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline (including herpes zoster) as judged by the investigator
  • Participants are not permitted to enroll into the study if they meet tuberculosis (TB) exclusion criteria
  • Previous treatment with galvokimig
Show all 9Show fewer
  • Participant has relevant safety events to one or more interleukin (IL)-13 biologic response modifiers (ie, dupilumab, tralokinumab and lebrikizumab) that resulted in discontinuation and change of treatment
  • All systemic therapies (other than biologics), topical therapies and other treatments for AtD must be discontinued at least 4 weeks prior to Baseline
  • Treatment with biologic agents must discontinued at least 3 months prior to baseline

Trial locations and contacts

59 sites in 9 countries.

59 sites in 9 countries

United States19 sites

  • Atd002 52013

    Boca Raton, Florida, 33486

  • Atd002 52014

    Bowling Green, Kentucky, 42104

  • Atd002 52017

    Chicago, Illinois, 60657

  • Atd002 52005

    Dallas, Texas, 75230

  • Atd002 52016

    Frisco, Texas, 75033

  • Atd002 52011

    Frisco, Texas, 75034

  • Atd002 52007

    Miami, Florida, 33126

  • Atd002 52003

    Miami, Florida, 33133

  • Atd002 52012

    New Albany, Indiana, 47150

  • Atd002 52022

    New York, New York, 10029-6574

  • Atd002 52021

    Oceanside, California, 92056

  • Atd002 52010

    Omaha, Nebraska, 68144

  • Atd002 52019

    Philadelphia, Pennsylvania, 19114

  • Atd002 52008

    Santa Monica, California, 90403

  • Atd002 52015

    Savannah, Georgia, 31419

  • Atd002 52004

    Sugar Land, Texas, 77479

  • Atd002 52020

    The Bronx, New York, 10455

  • Atd002 52009

    Troy, Michigan, 48084

  • Atd002 52018

    Wheaton, Illinois, 60189

Other trials in United States

Poland13 sites

  • Atd002 45011

    Chorzów

  • Atd002 45001

    Katowice

  • Atd002 45003

    Krakow

  • Atd002 45007

    Krakow

  • Atd002 45010

    Krakow

  • Atd002 45014

    Krakow

  • Atd002 45004

    Lodz

  • Atd002 45013

    Lodz

  • Atd002 45005

    Sosnowiec

  • Atd002 45009

    Tarnów

  • Atd002 45002

    Warsaw

  • Atd002 45006

    Warsaw

  • Atd002 45008

    Wroclaw

Other trials in Poland

Bulgaria6 sites

  • Atd002 41004

    Lovech

  • Atd002 41001

    Pleven

  • Atd002 41007

    Plovdiv

  • Atd002 41002

    Sevlievo

  • Atd002 41005

    Sofia

  • Atd002 41006

    Sofia

Other trials in Bulgaria

Japan6 sites

  • Atd002 21001

    Habikino

  • Atd002 21007

    Nagoya

  • Atd002 21005

    Sakai

  • Atd002 21008

    Sapporo

  • Atd002 21004

    Tachikawa-shi

  • Atd002 21006

    Yokohama

Other trials in Japan

Czechia5 sites

  • Atd002 42002

    Náchod

  • Atd002 42001

    Prague

  • Atd002 42003

    Prague

  • Atd002 42004

    Prague

  • Atd002 42005

    Prague

Other trials in Czechia

Canada4 sites

  • Atd002 51002

    Edmonton

  • Atd002 51006

    Hamilton

  • Atd002 51007

    Toronto

  • Atd002 51003

    Vancouver

Other trials in Canada

Germany3 sites

  • Atd002 43001

    Bad Bentheim

  • Atd002 43004

    Leipzig

  • Atd002 43007

    Mahlow

Other trials in Germany

United Kingdom2 sites

  • Atd002 46004

    London

  • Atd002 46003

    Salford

Other trials in United Kingdom

Hungary1 site

  • Atd002 44001

    Debrecen

Other trials in Hungary

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Moderate to Severe Atopic Dermatitis

The purpose of the study is to evaluate the dose-response relationship of galvokimig compared with placebo in study participants with moderate-to-severe atopic dermatitis (AtD).

Being tested
Galvokimig, Placebo
Keywords
Atopic Dermatitis, Galvokimig,, 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.

  • GalvokimigBiological

    Also called UCB9741

    Drug: Galvokimig Pharmaceutical form: Solution for injection

  • PlaceboDrug

    Drug: Placebo Pharmaceutical form: Solution for injection

Study groups in NCT07277660
Study groupRoleWhat they receive
Galvokimig Arm 1ExperimentalParticipants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
Receives: Biological: Galvokimig
Galvokimig Arm 2ExperimentalParticipants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
Receives: Biological: Galvokimig
Galvokimig Arm 3ExperimentalParticipants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
Receives: Biological: Galvokimig
PlaceboPlacebo comparatorParticipants will receive matching placebo during Initial Intervention Period. After week 16 participants will continue on the same or a dose galvokimig.
Receives: Biological: Galvokimig; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16

    The EASI is a validated scoring system that grades the physical signs of atopic dermatitis/eczema.

    The severity of each clinical sign is scored as: 0=None to 3=Severe.

    Measured: Week 16

Secondary outcomes (4)

  1. Percentage of Participants with validated Investigator Global Assessment (vIGA) response at Week 16

    The vIGA score is using descriptors that best describe the overall appearance of the lesions at a given time point. Assessment: vIGA 0=clear to 4=severe

    Measured: Week 16

  2. Change from Baseline in weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16

    The PP-NRS is a single item patient-reported outcome (PRO) measure assessing the worst itch in the last 24 hours. It will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."

    Measured: Baseline and Week 16

  3. Incidence of Treatment-Emergent (TE) Adverse Events (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention until 8 weeks after final administration.

    Measured: Up to Week 58

  4. Incidence of TE Serious Adverse Events (SAEs)

    An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed:

    • Results in death
    • Is life-threatening
    • Requires inpatient hospitalization or prolongation of existing hospitalization
    • Results in persistent or significant disability/incapacity
    • 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: Up to Week 58

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study start29 Dec 2025
  3. Primary completion17 May 2027 (estimated)
  4. Study completion6 Mar 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07277660
Sponsor's protocol ID
ATD002
Other IDs
2025-522578-35, U1111-1326-9886, 2025
Acronym
PossibILity
Status last verified
Sep 2026
First submitted
2 Dec 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
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 pre-specified 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Galvokimig in people with Atopic Dermatitis, run by UCB Biopharma SRL at 59 sites in 9 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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Poland, Bulgaria, Japan, Czechia and 4 more countries. 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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?

Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07277660.

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 25 Sep 2026.

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PossibILity Clinical Trial NCT07277660 | AzTrials