Atopic DermatitisPhase 2NCT06436183
A Study of the Effects of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing Camoteskimab in people with Atopic Dermatitis and Atopic, run by Apollo Therapeutics Ltd at 35 sites in 2 countries.
Trial summary
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension to evaluate the efficacy and safety of camoteskimab in adults with moderate to severe AD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis, Atopic, Dermatitis
- What is being tested?
- Camoteskimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 35 sitesin 2 countries
- Study dates
- 1 May 2024to 12 Aug 2025
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be 18-75 years of age inclusive, at the time of signing the informed consent.
- Chronic AD for at least 1 year.
- Participants with moderate to severe AD defined by:
- Investigator global assessment (IGA) score of ≥ 3 (on a scale of 0 to 4, in which three is moderate and four is severe) at Baseline.
- AD involvement of ≥ 10% body surface area (BSA) at Baseline.
- EASI score of ≥ 12 at Baseline.
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- Pruritus numerical rating scale (NRS) ≥ 4 at Baseline.
- Participants who are candidates for systemic therapy, defined as inadequate response to treatment with topical medications, or for whom topical treatments are otherwise medically inadvisable.
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Female participants:
- Sexually active females of childbearing potential must agree to use two forms of accepted methods of highly effective forms of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes:
- IUD plus one barrier method.
- Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method.
- 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or
- A vasectomized partner*.
- Male participants:
- Sexually active male participants and males and who are partners of females of childbearing potential agree to use two forms of contraception as above and to not donate sperm or try to conceive during the treatment period and for at least 3 months after the last dose of study drug.
- Participant provides signed informed consent.
Who cannot join
- Participant has history of use of more than two (2) prior systemic therapies for AD (e.g.
- biologics or JAKi) and who used any of these medications as follows:
- Dupilumab, tralokinumab, lebrikizumab within 8 weeks prior to Baseline.
- Systemic JAKi within 4 weeks prior to Baseline.
- TCS, TCI, topical phosphodiesterase-4 (PDE4) inhibitors, and topical JAKi within 7 days prior to enrollment (at Baseline) or more than five half-lives whichever is longer.
- Participant has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of AD or would interfere with the study assessments.
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- Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma).
- Any clinically significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically significant abnormalities in the 12- lead ECG as considered by the perfusion index that may interfere with the interpretation of QTc interval changes.
- Participant has AD involving ocular symptoms, or blepharitis, conjunctivitis, or keratitis diagnosed within the last 60 days prior to the screening visit, requiring chronic ocular corticosteroid treatment.
- Participant has severe or uncontrolled seasonal or allergic rhinitis, asthma or any other non-AD disease as judged by the Investigator. Participants with seasonal or allergic rhinitis, asthma or any other non-AD disease requiring use of intranasal or inhaled corticosteroid that is stable and well-controlled are not excluded.
- Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test; Active hepatitis B virus (HBV): confirmed hepatitis B surface antigen (HBs Ag) positive (+) or hepatitis B core antibody (HBc Ab) positive (+); Active hepatitis C virus (HCV): Confirmed hepatitis C antibody positive (+); evidence of active or latent TB
- Diagnosed with a malignancy within 5 years of enrollment (suspected malignancy should be ruled out by blood or tissue biopsy, as applicable) with the exception of
- Completely resected basal call or squamous cell carcinoma of the skin.
- Carcinoma in situ of the cervix.
- Has had previous exposure to anti-IL-18 therapy.
- Treatment with any investigational agent, or any investigational device or procedure, within 28 days (or 5 half- lives, whichever is greater) of screening.
- Has any of the following laboratory findings
- Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2.
- Hemoglobin ≤8 g/dL.
- Neutrophils ≤1,500/μL.
- Platelets ≤75,000/μL.
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States30 sites
Renaissance Research and Medical Group
Cape Coral, Florida, 33991
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
First OC Dermatology Research, Inc.
Fountain Valley, California, 92708
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Rodgers Dermatology
Frisco, Texas, 75034
Center for Clinical Studies
Houston, Texas, 77004
Clinical Trial Network
Houston, Texas, 77074
Dawes Fretzin Clinical Research
Indianapolis, Indiana, 46250
California Allergy and Asthma Medical Group
Los Angeles, California, 90025
University of California Los Angeles Dermatology
Los Angeles, California, 90095
Skin Sciences, PLLC
Louisville, Kentucky, 40217
D&H National Research Centers, Inc.
Miami, Florida, 33155
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, 61761
Amicis Research Center (Northridge)
Northridge, California, 91324
Central Sooner Research
Oklahoma City, Oklahoma, 73071
Unity Clinical Research - Dermatology
Oklahoma City, Oklahoma, 73118
Skin Specialists PC
Omaha, Nebraska, 68144
Owensboro Dermatology Associates
Owensboro, Kentucky, 42303
Cura Clinical Research
Oxnard, California, 93030
Paddington Testing Co. Inc
Philadelphia, Pennsylvania, 19103
Medical Dermatology Specialists, PC/US Dermatology Partners
Phoenix, Arizona, 85006
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
Advanced Dermatology and Skin Cancer Center - Saint Joseph
Saint Joseph, Missouri, 64506
VASDHS - Veterans Affairs San Diego Medical Center
San Diego, California, 92161
Clinical Sciences Institute
Santa Monica, California, 90404
Avita Clinical Research - Dermatology
Tampa, Florida, 33613
Revival Research Institute
Troy, Michigan, 48084
Somerset Skin Centre
Troy, Michigan, 48084
Michigan Dermatology Institute
Waterford, Michigan, 28329
ObjectiveHealth-The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina, 27103
Canada5 sites
Youthful Image
Edmonton, Alberta, T5J 3S9
Rejuvenation Dermatology Clinic Edmonton South
Edmonton, Alberta, T6W 0J5
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9
Clinique Medicale Saint-Louis
Québec, Quebec, G1W 4R4
Clinique Dermatologique de Sherbrooke
Sherbrooke, Quebec, J1G 1X9
About this study
Official title: A Phase 2a, Multicenter, Randomized, Double-blind, 16-week Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension to evaluate the efficacy and safety of camoteskimab in adults with moderate to severe AD.
Read the detailed description
This study contains two parts: Parts 1 and Part 2.
Part 1 (Blinded Period):
Eligible patients will be randomized in a 1:1:1 ratio to receive either camoteskimab dose 1, camoteskimab dose 2 or placebo.
Part 2 (Extension Period):
In part 2, all participants will receive camoteskimab.
- Conditions
- Atopic Dermatitis, Atopic, Dermatitis, Dermatologic Disease, Eczema, Eczema Atopic Dermatitis
- Being tested
- Camoteskimab, Placebo
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Skin Diseases, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamoteskimabDrug
Also called APL-9109, AVTX-007, CERC-007, AEVI-007
Drug Product
PlaceboDrug
Inactive substance
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Camoteskimab Receives: Drug: Camoteskimab |
| Dose 2 | Experimental | Camoteskimab Receives: Drug: Camoteskimab; Drug: Placebo |
| Placebo | Placebo comparator | Dummy version of the study drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 12
An EASI score is a tool used to measure the extent (area) and severity of atopic eczema. The EASI utilizes area assessments that rate the four involved regions on a 0% to 100% scale for each region. The scores are added up for each of the four body regions (head, arms, trunk, and legs). For each of these components, the individual scores are added together to calculate the EASI score, which ranges from 0 to 72. The higher the EASI score, the more severe the AD.
Measured: 12 weeks
Secondary outcomes (11)
Percent change from baseline in EASI score at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
Measured: 12 Weeks
Change from baseline in EASI score at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
Measured: 12 weeks
Proportion of participants achieving a 50, 75, 90 and 100% improvement from baseline in EASI (EASI-50, 75, 90 and 100) at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
Measured: 12 weeks
Proportion of participants with an IGA 0/1 and a decrease in IGA of ≥ 2 points at Week 12
To further assess the efficacy of camoteskimab in participants with AD via Investigator's Global Assessment Scale (IGA), which provides a global clinical assessment of AD severity.
Measured: 12 weeks
Change from baseline in peak pruritus score at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.
Measured: 12 weeks
Proportion of participants with an improvement of ≥ 4 or more points in peak pruritus weekly score at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.
Measured: 12 weeks
Change from baseline in POEM score at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Patient-Oriented Eczema Measure (POEM) which assesses disease systems.
Measured: 12 weeks
Change from baseline in DLQI score at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Dermatology Life Quality Index (DLQI) which assesses quality of life.
Measured: 12 weeks
Change from baseline in AD involvement by BSA at Week 12
To further assess the efficacy of camoteskimab in participants with AD via Body Surface Area (BSA) which assesses the percentage of the total skin affected by AD.
Measured: 12 weeks
Change from baseline in SP-NRS at Week 12
To further assess the efficacy of camoteskimab in participants with AD via the Skin Pain Numerical Rating Scale (SP-NRS) which assesses skin pain.
Measured: 12 weeks
Change from baseline in PROMIS-SRI-SF-8a score at Week 12 reported outcomes
To further assess the efficacy of camoteskimab in participants with AD via Patient Reported Outcomes Measurement Information System (PROMIS) which measures patient-reported health status for physical, mental, and social well-being.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 May 2024
- Primary completion26 Mar 2025
- Study completion12 Aug 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.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apollo Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436183
- Sponsor's protocol ID
- AP43CP03
- Status last verified
- May 2025
- First submitted
- 9 Apr 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Randomized, Double-blind, 16-week Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06436183
- Acronym / sponsor ID
- AP43CP03
- Conditions
- Atopic Dermatitis, Atopic, Dermatitis, Dermatologic Disease, Eczema, Eczema Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Apollo Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 30 May 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.
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension to evaluate the efficacy and safety of camoteskimab in adults with moderate to severe AD.
Detailed description
This study contains two parts: Parts 1 and Part 2.
Part 1 (Blinded Period):
Eligible patients will be randomized in a 1:1:1 ratio to receive either camoteskimab dose 1, camoteskimab dose 2 or placebo.
Part 2 (Extension Period):
In part 2, all participants will receive camoteskimab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: CamoteskimabCamoteskimab |
| Dose 2 | Experimental | Drug: Camoteskimab, Drug: PlaceboCamoteskimab |
| Placebo | Placebo comparator | Drug: PlaceboDummy version of the study drug |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participants must be 18-75 years of age inclusive, at the time of signing the informed consent.
- Chronic AD for at least 1 year.
- Participants with moderate to severe AD defined by:
- Participants who are candidates for systemic therapy, defined as inadequate response to treatment with topical medications, or for whom topical treatments are otherwise medically inadvisable.
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Key exclusion criteria (21 listed)
- Participant has history of use of more than two (2) prior systemic therapies for AD (e.g.
- Participant has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of AD or would interfere with the study assessments.
- Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma).
- Any clinically significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically significant abnormalities in the 12- lead ECG as considered by the perfusion index that may interfere with the interpretation of QTc interval changes.
- Participant has AD involving ocular symptoms, or blepharitis, conjunctivitis, or keratitis diagnosed within the last 60 days prior to the screening visit, requiring chronic ocular corticosteroid treatment.
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 |
|---|---|---|
| CamoteskimabAlso: APL-9109, AVTX-007, CERC-007, AEVI-007Drug Product | Drug | Dose 1, Dose 2 |
| PlaceboInactive substance | Drug | Dose 2, Placebo |
Primary outcome
Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 12
Time frame: 12 weeks
An EASI score is a tool used to measure the extent (area) and severity of atopic eczema. The EASI utilizes area assessments that rate the four involved regions on a 0% to 100% scale for each region. The scores are added up for each of the four body regions (head, arms, trunk, and legs). For each of these components, the individual scores are added together to calculate the EASI score, which ranges from 0 to 72. The higher the EASI score, the more severe the AD.
11 secondary outcomes
Percent change from baseline in EASI score at Week 12
Time frame: 12 Weeks
Change from baseline in EASI score at Week 12
Time frame: 12 weeks
Proportion of participants achieving a 50, 75, 90 and 100% improvement from baseline in EASI (EASI-50, 75, 90 and 100) at Week 12
Time frame: 12 weeks
Proportion of participants with an IGA 0/1 and a decrease in IGA of ≥ 2 points at Week 12
Time frame: 12 weeks
Change from baseline in peak pruritus score at Week 12
Time frame: 12 weeks
Proportion of participants with an improvement of ≥ 4 or more points in peak pruritus weekly score at Week 12
Time frame: 12 weeks
Change from baseline in POEM score at Week 12
Time frame: 12 weeks
Change from baseline in DLQI score at Week 12
Time frame: 12 weeks
Change from baseline in AD involvement by BSA at Week 12
Time frame: 12 weeks
Change from baseline in SP-NRS at Week 12
Time frame: 12 weeks
Change from baseline in PROMIS-SRI-SF-8a score at Week 12 reported outcomes
Time frame: 12 weeks
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 18 Sep 2025.
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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.
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camoteskimab in people with Atopic Dermatitis and Atopic, run by Apollo Therapeutics Ltd at 35 sites in 2 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 18 inclusion and 21 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 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada. 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?
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?
Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 12 (time frame: 12 weeks). 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 18 Sep 2025.