Atopic DermatitisPhase 2NCT06727552
A Study of Barzolvolimab in Patients With Atopic Dermatitis
A Phase 2 study testing Barzolvolimab in people with Atopic Dermatitis, run by Celldex Therapeutics at 33 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis 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?
- Barzolvolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 33 sitesUnited States
- Study dates
- 18 Dec 2024to Dec 2026
- 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
- Male or female ≥ 18 years of age
- Diagnosis of chronic atopic dermatitis (AD) for at least 1 year
- Onset of symptoms at least 1 year prior and current symptoms consistent with moderate to severe AD as defined by:
- EASI ≥ 12 at Visit 1 and EASI ≥ 16 at Visit 2
- Body Surface Area of Involvement (BSA) ≥ 10% at Visit 1 and Visit 2
- IGA score ≥ 3 at Visit 1 and Visit 2
Show all 9Show fewer
- Severe itch, defined by weekly average of daily PP-NRS score of ≥ 5, during the 7 days prior to treatment
- Documented history of inadequate response to treatment with topical medications or for whom topical medications are otherwise medically inadvisable.
- Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
Who cannot join
- Any other active pruritic skin diseases that would confound AD assessments based on the Investigator's clinical judgment.
- Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Visit 1.
- Planned or anticipated use of any prohibited medications at any time during the study.
- Prior receipt of barzolvolimab or other anti-KIT therapy. There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Ohara Aivaz MD Dermatology
Beverly Hills, California, 90212
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, 35244
Treasure Valley Medical Research
Boise, Idaho, 83706
Equity Medical LLC
Bowling Green, Kentucky, 42104
Advanced Dermatology Center - Burbank
Burbank, California, 91506
Center for Medical Dermatology + Immunology Research
Chicago, Illinois, 60657
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236
Centricity Research Columbus Dermatology
Columbus, Georgia, 31904
Zenos Clinical Research
Dallas, Texas, 75230
Onyx Clinical Research - Michigan
Flint, Michigan, 48532
Direct Helpers Research Center
Hialeah, Florida, 33012
310 Clinical Research
Inglewood, California, 90301
Avance Trials
Laguna Niguel, California, 92677
Excel Clinical Research
Las Vegas, Nevada, 89109
LA Universal Research Center, Inc.
Los Angeles, California, 90057
UCLA Division of Dermatology
Los Angeles, California, 90089
International Dermatology Research Inc - Miami
Miami Lakes, Florida, 33144
Equity Medical, LLC
New York, New York, 10023
OptiSkin Medical
New York, New York, 10128
Sneeze Wheeze and Itch Associates LLC
Normal, Illinois, 61761
Allergy and Asthma Specialists PSC
Owensboro, Kentucky, 42301
Dynasty Dermatology
Pasadena, California, 91105
Acclaim Clinical Research
San Diego, California, 92120
Sarasota Clinical Research
Sarasota, Florida, 34233
Georgia Skin and Cancer Clinic
Savannah, Georgia, 31419
Palmetto Clinical Trial Services LLC
Simpsonville, South Carolina, 29615
Jordan Valley Dermatology Center - South Jordan
South Jordan, Utah, 84095
Well Pharma Medical Research Corporation
South Miami, Florida, 33173
Sienna Dermatology
Sugar Land, Texas, 77479
Revival Research Institute, LLC
Troy, Michigan, 48084
FOMAT Medical Research - Allergy, Asthma, & Immunology Medical Group
Ventura, California, 93003
Center for Clinical Studies LTD.LLP
Webster, Texas, 77598
Focus Clinical Research
West Hills, California, 91307
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Moderate to Severe Atopic Dermatitis
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis
Read the detailed description
This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of barzolvolimab (CDX-0159) in adult participants with Atopic Dermatitis.
There is a screening period of up to 28 days, a 16-week double-blind, placebo-controlled treatment period, a 16-week double-blind, active treatment period, and a 16-week follow-up period. On Day 1, participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg [Arm 1], 300 mg Q4W after an initial loading dose of 450 mg [Arm 2], or placebo Q4W [Arm 3]. At Week 16, participants on placebo will be re-randomized on a 1:1 ratio to receive barzolvolimab by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg. Participants on Arms 1 and 2 will undergo a mock re-randomization at Week 16 to maintain the blind.
- Conditions
- Atopic Dermatitis
- Being tested
- Barzolvolimab, Matching placebo
- Keywords
- AD, Atopic Dermatitis, eczema, barzolvolimab, CDX-0159, CDX0159-15
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BarzolvolimabBiological
Subcutaneous Administration
Matching placeboDrug
Subcutaneous Administration
| Study group | Role | What they receive |
|---|---|---|
| Barzolvolimab 150 mg | Experimental | Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 32 weeks Receives: Biological: Barzolvolimab |
| Barzolvolimab 300 mg | Experimental | Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 300 mg administered every 4 weeks for 32 weeks Receives: Biological: Barzolvolimab |
| Placebo then barzolvolimab 150 mg | Experimental | Placebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 150 mg administered every 4 weeks for 16 weeks. Receives: Biological: Barzolvolimab; Drug: Matching placebo |
| Placebo then barzolvolimab 300 mg | Experimental | Placebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 300 mg administered every 4 weeks for 16 weeks. Receives: Biological: Barzolvolimab; Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16
Evaluate the clinical efficacy of 2 dose levels (150 mg and 300 mg) of barzolvolimab, compared to placebo, in adult participants with moderate to severe atopic dermatitis (AD) using the PP-NRS. The PP-NRS ranges from 0 = "no itch" to 10 ="worst imaginable itch" for the worst intensity itch in the preceding 24-hr period.
Measured: From Day 1 (first dose) to Day 113 (week 16)
Secondary outcomes (2)
Percent change from Baseline in Eczema Area Severity Index (EASI) score at Week 16.
A total EASI score range from 0 to 72 points will be recorded for each assessment, with higher scores reflecting worse severity of AD.
- 0 = clear
- 0.1-1.0 = almost clear
- 1.1-7.0 = mild
- 7.1-21.0 = moderate
- 21.1-50.0 = severe
- 50.1-72.0 = very severe
Measured: From Day 1 (first dose) to Day 113 (week 16)
Proportion of participants achieving an Investigator Global Assessment (IGA) score of "0" or "1" at Week 16.
The IGA determines severity of AD and clinical response to treatment on a static 5-point scale based on erythema and papulation/infiltration
- 0 = Clear
- 1 = Almost clear
- 2 = Mild
- 3 = Moderate
- 4 = Severe
Measured: From Day 1 (first dose) to Day 113 (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start18 Dec 2024
- Primary completion6 May 2026
- Study completionDec 2026 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727552
- Sponsor's protocol ID
- CDX0159-15
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06727552
- Acronym / sponsor ID
- CDX0159-15
- Conditions
- Atopic Dermatitis
- Keywords
- AD, Atopic Dermatitis, eczema, barzolvolimab, CDX-0159, CDX0159-15
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Dec 2024 (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 this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis
Detailed description
This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of barzolvolimab (CDX-0159) in adult participants with Atopic Dermatitis.
There is a screening period of up to 28 days, a 16-week double-blind, placebo-controlled treatment period, a 16-week double-blind, active treatment period, and a 16-week follow-up period. On Day 1, participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg [Arm 1], 300 mg Q4W after an initial loading dose of 450 mg [Arm 2], or placebo Q4W [Arm 3]. At Week 16, participants on placebo will be re-randomized on a 1:1 ratio to receive barzolvolimab by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg. Participants on Arms 1 and 2 will undergo a mock re-randomization at Week 16 to maintain the blind.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Barzolvolimab 150 mg | Experimental | Biological: BarzolvolimabBarzolvolimab loading dose of 450 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 32 weeks |
| Barzolvolimab 300 mg | Experimental | Biological: BarzolvolimabBarzolvolimab loading dose of 450 mg subcutaneous injection followed by 300 mg administered every 4 weeks for 32 weeks |
| Placebo then barzolvolimab 150 mg | Experimental | Biological: Barzolvolimab, Drug: Matching placeboPlacebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 150 mg administered every 4 weeks for 16 weeks. |
| Placebo then barzolvolimab 300 mg | Experimental | Biological: Barzolvolimab, Drug: Matching placeboPlacebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 300 mg administered every 4 weeks for 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥ 18 years of age
- Diagnosis of chronic atopic dermatitis (AD) for at least 1 year
- Onset of symptoms at least 1 year prior and current symptoms consistent with moderate to severe AD as defined by:
- Documented history of inadequate response to treatment with topical medications or for whom topical medications are otherwise medically inadvisable.
- Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
Key exclusion criteria (4 listed)
- Any other active pruritic skin diseases that would confound AD assessments based on the Investigator's clinical judgment.
- Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Visit 1.
- Planned or anticipated use of any prohibited medications at any time during the study.
- Prior receipt of barzolvolimab or other anti-KIT therapy. There are additional criteria that your study doctor will review with you to confirm you are eligible for the 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 |
|---|---|---|
| BarzolvolimabSubcutaneous Administration | Biological | Barzolvolimab 150 mg, Barzolvolimab 300 mg, Placebo then barzolvolimab 150 mg, Placebo then barzolvolimab 300 mg |
| Matching placeboSubcutaneous Administration | Drug | Placebo then barzolvolimab 150 mg, Placebo then barzolvolimab 300 mg |
Primary outcome
Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16
Time frame: From Day 1 (first dose) to Day 113 (week 16)
Evaluate the clinical efficacy of 2 dose levels (150 mg and 300 mg) of barzolvolimab, compared to placebo, in adult participants with moderate to severe atopic dermatitis (AD) using the PP-NRS. The PP-NRS ranges from 0 = "no itch" to 10 ="worst imaginable itch" for the worst intensity itch in the preceding 24-hr period.
2 secondary outcomes
Percent change from Baseline in Eczema Area Severity Index (EASI) score at Week 16.
Time frame: From Day 1 (first dose) to Day 113 (week 16)
Proportion of participants achieving an Investigator Global Assessment (IGA) score of "0" or "1" at Week 16.
Time frame: From Day 1 (first dose) to Day 113 (week 16)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Barzolvolimab in people with Atopic Dermatitis, run by Celldex Therapeutics at 33 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 9 inclusion and 4 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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. 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?
Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16 (time frame: From Day 1 (first dose) to Day 113 (week 16)). 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 11 Aug 2026.