Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT07277660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI is a validated scoring system that grades the physical signs of atopic dermatitis/eczema.\n\nThe severity of each clinical sign is scored as: 0=None to 3=Severe.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with validated Investigator Global Assessment (vIGA) response at Week 16', 'timeFrame': 'Week 16', 'description': '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'}, {'measure': 'Change from Baseline in weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': '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."'}, {'measure': 'Incidence of Treatment-Emergent (TE) Adverse Events (AE)', 'timeFrame': 'Up to Week 58', 'description': '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.'}, {'measure': 'Incidence of TE Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Week 58', 'description': 'An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed:\n\n* Results in death\n* Is life-threatening\n* Requires inpatient hospitalization or prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect\n* 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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic Dermatitis', 'Galvokimig,', 'UCB9741'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant must be aged greater than or equal (≥)18 years at the time of signing the informed consent\n* 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:\n\n 1. validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline\n 2. Eczema Area and Severity Index (EASI) score ≥16 at both Screening and Baseline\n 3. Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥4 at both Screening and Baseline\n 4. ≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline\n 5. 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\n\nExclusion Criteria:\n\n* 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\n* 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\n* Presence or family history (first degree) of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)\n* 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\n* Participants are not permitted to enroll into the study if they meet tuberculosis (TB) exclusion criteria\n* Previous treatment with galvokimig\n* 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\n* All systemic therapies (other than biologics), topical therapies and other treatments for AtD must be discontinued at least 4 weeks prior to Baseline\n* Treatment with biologic agents must discontinued at least 3 months prior to baseline"}, 'identificationModule': {'nctId': 'NCT07277660', 'briefTitle': 'A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ATD002'}, 'secondaryIdInfos': [{'id': '2025-522578-35', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}, {'id': 'U1111-1326-9886', 'type': 'OTHER', 'domain': 'Universal Trial Number (UTN)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Galvokimig Arm 1', 'description': 'Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.', 'interventionNames': ['Biological: Galvokimig']}, {'type': 'EXPERIMENTAL', 'label': 'Galvokimig Arm 2', 'description': 'Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.', 'interventionNames': ['Biological: Galvokimig']}, {'type': 'EXPERIMENTAL', 'label': 'Galvokimig Arm 3', 'description': 'Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.', 'interventionNames': ['Biological: Galvokimig']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive matching placebo during Initial Intervention Period. After week 16 participants will continue on the same or a dose galvokimig.', 'interventionNames': ['Biological: Galvokimig', 'Drug: Placebo']}], 'interventions': [{'name': 'Galvokimig', 'type': 'BIOLOGICAL', 'otherNames': ['UCB9741'], 'description': 'Drug: Galvokimig Pharmaceutical form: Solution for injection', 'armGroupLabels': ['Galvokimig Arm 1', 'Galvokimig Arm 2', 'Galvokimig Arm 3', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Drug: Placebo Pharmaceutical form: Solution for injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'UCB Cares', 'role': 'CONTACT', 'email': 'ucbcares@ucb.com', 'phone': '+18445992273'}, {'name': 'UCB Cares', 'role': 'CONTACT', 'email': 'UCBCares@ucb.com', 'phone': '0018445992273'}], 'overallOfficials': [{'name': 'UCB Cares', 'role': 'STUDY_DIRECTOR', 'affiliation': '001 844 599 22733'}]}, 'ipdSharingStatementModule': {'url': 'http://www.Vivli.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Biopharma SRL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}