Atopic DermatitisPhase 2NCT07599813
A Phase 2b 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 85 sites in 8 countries.
Trial summary
This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis, Atopic, Dermatitis
- What is being tested?
- Camoteskimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 85 sitesin 8 countries
- Study dates
- 28 May 2026to 30 Apr 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 inclusive, at the time of signing the informed consent.
- Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria.
- 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 Screening and Baseline.
- AD involvement of ≥ 10% body surface area (BSA) at Screening and Baseline.
- EASI score of ≥ 16 at Screening and at Baseline.
Show all 10Show fewer
- Peak pruritus numerical rating scale (PP-NRS) ≥ 4 at Baseline. Note: The PP-NRS will be calculated from the 7 consecutive days immediately preceding Baseline. A minimum of 4 daily scores out of the 7 days is needed.
- Participants who are candidates for systemic therapy, defined as history of inadequate response to topical AD treatments applied for at least 28 days, or for the maximum duration recommended by the product prescribing information, or for treatment with topical AD treatments is medically inadvisable due to important side effects or safety risks.
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participant provides signed informed consent
Who cannot join
- History or other evidence of severe illness or any other conditions such as psychiatric illness, severe depression or previous history of suicidal attempt in past 10 years that would render the participant, in the opinion of the Investigator, unsuitable for the study.
- Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline.
- 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 based on the Investigator's judgement.
- Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator.
- Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma) based on investigator judgement.
- 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 Investigator that may interfere with the interpretation of QTc interval changes.
Show all 35Show fewer
- Participant has severe and uncontrolled seasonal or allergic rhinitis, severe and uncontrolled asthma or any other severe and uncontrolled atopic disease as judged by the Investigator.
- Treatment of AD with medicated moisturizers available only by prescription within 2 weeks prior to the Baseline visit.
- Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test.
- Active hepatitis B virus (HBV): hepatitis B surface antigen (HBs Ag) positive (+) or hepatitis B core antibody (HBc Ab) positive (+) confirmed by HBV PCR positive (+).
- Active hepatitis C virus (HCV): If hepatitis C antibody positive (+), confirmed by HCV RNA test. Note: a participant with documented proof of cure from HCV may be enrolled.
- Evidence of active or latent tuberculosis.
- Receipt of live or attenuated live vaccine within 6 weeks prior to screening.
- Participant had a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
- Participant is known to have immune deficiency or is immunocompromised
- 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 cell or squamous cell carcinoma of the skin.
- Carcinoma in situ of the cervix.
- Has had previous exposure to anti-IL-18 therapy.
- Known allergy/sensitivity to any component of IMP.
- History of use of any of these medications as follows:
- Dupilumab, tralokinumab, lebrikizumab, nemolizumab within 8 weeks prior to Baseline.
- Systemic JAKi within 4 weeks prior to Baseline.
- Any topical medicated treatment that could affect AD within 2 weeks prior to Baseline, including, but not limited to, topical corticosteroids, topical phosphodiesterase (PDE4) inhibitors, topical calcineurin inhibitors, topical JAKi, tars, antimicrobials, medical devices, and bleach baths.
- Systemic therapies (other than biologics) that could affect AD not noted above, within 4 weeks prior to Baseline, including but not limited to, retinoids, calcineurin inhibitors, methotrexate, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids. Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.
- Treatment with any investigational biologic agent or biologic agent approved after publication of this protocol, within 12 weeks (or 5 half-lives, whichever is greater) of screening.
- Treatment with any investigational nonbiologic agent, or any investigational device or procedure, within 4 weeks (or 5 half-lives, whichever is greater) of screening.
- UV-B phototherapy (including tanning beds) or excimer laser use within 4 weeks prior to Baseline or during the study.
- PUVA treatment within 4 weeks prior to Baseline
- Sedating antihistamines, including but not limited to doxepin, hydroxyzine or diphenhydramine within 1 week prior to Baseline
- Topical products containing urea within 1 week prior to Baseline
- Systemic antibiotics within 2 weeks or topical antibiotics within 1 week prior to Baseline
- Intravenous immunoglobulin (IVIg) therapy within 12 weeks prior to Baseline.
- Female participant who is pregnant or breastfeeding or trying to conceive.
- Participant considered unlikely to adhere to treatment and/or follow the protocol in the opinion of the Investigator.
Trial locations and contacts
85 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
85 sites in 8 countries
United States33 sites, 33 recruiting
- Recruiting
AllerVie Clinical Research
Birmingham, Alabama, 35209
Kendra Williams, 205-209-4101, ACRAdmin@allervie.com
- Recruiting
Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, 35244
Jennifer Perry, 205-778-1564, jperry@cahabaderm.com
- Recruiting
Dermatology Trial Associates, Inc
Bryant, Arkansas, 72022
Tim Dugan, 501-655-6138, tdugan@burkepharmaceutical.com
- Recruiting
Best Skin Research, LLC
Camp Hill, Pennsylvania, 17011
Erin McDonald, 717-385-5426, erin@bestskinresearch.com
- Recruiting
ABMED Clinical Research Corp.
Cape Coral, Florida, 33904
Jorge Remedios, 239-471-7595, jorger@abmedclinicalresearch.com
- Recruiting
DS Research of Southern Indiana,LLC
Clarksville, Indiana, 47129
Megan Vissing, 812-213-9769, mvissing@dsresearch.com
- Not yet recruiting
Trail Horizon
Clifton, New Jersey, 07013
Chirag Patel, 732-798-0301, cpatel@trialhorizon.com
- Recruiting
ClinOhio Research Services
Columbus, Ohio, 43213
Kelly Thomas, 614-683-5800, Kthomas@clinohioresearch.com
- Recruiting
Red River Research Partners, LLC
Fargo, North Dakota, 58103
Gunar Loftsgard, 701-997-1510, gunar@redriverresearchpartners.com
- Recruiting
Skin Care Research
Hollywood, Florida, 33021
Kimberly Gardner, 954-674-3535, Kgardner@dermcaremgt.com
- Recruiting
Marvel Research, LLC
Huntington Beach, California, 92648
Mathew Campos, 714-375-5970, mcampos@marvelclinical.com
- Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Joannie Prusa, 317-516-5030, jprusa@ecommunity.com
- Recruiting
Metropolis Dermatology
Los Angeles, California, 90025
Jayda Pham, 424-393-0005, jayda.pham@metropolisderm.com
- Recruiting
Dermatology Research Associates
Los Angeles, California, 90048
Nadia Trejo, 310-337-7171, ntrejo@drsofen.com
- Not yet recruiting
University of California Los Angeles
Los Angeles, California, 90095
Hamiya Askaryar, 424-365-4129, haskaryar@mednet.ucla.edu
- Recruiting
Ada West Research, LLC
Meridian, Idaho, 83646
Stacy Gonzales, 208-279-1520, research@adawestdermatology.com
- Recruiting
Quality Care Clinical Research
Miami, Florida, 33101
Mariano Sanso, 305-906-1994, msanso@qualitycareclinicalresearch.com
- Recruiting
FXM Clinical Research Miami, LLC
Miami, Florida, 33155
FXM Administrative, 954-368-4406, info@fxmresearch.com
- Recruiting
Sadick Research Group, LLC
New York, New York, 10021
Zoe Ataker, 212-772-7243, zoe.ataker@sadickdermatology.com
- Not yet recruiting
Eminent Clinical Research and Associates
North Lauderdale, Florida, 33068
Marie Moore, 954-366-5373, admin@eminentclinicalresearch.com
- Recruiting
Ziaderm Research LLC
North Miami Beach, Florida, 33162
Tory Sullivan, 305-652-8600, drtory@sullivandermatology.com
- Recruiting
Northridge Clinical Trials
Northridge, California, 91325
Evelyn Jasso, 818-350-7483, ejasso@northridgetrials.com
- Recruiting
Chesapeake Clinical Research, Inc
Pasadena, Maryland, 21122
Jonathan Matz, 410-931-1966, jonathanmatz@yahoo.com
- Recruiting
Saguaro Dermatology Associates
Phoenix, Arizona, 85018
Dathan Hamann, 480-562-3610, clinicaltrials@saguaroderm.com
- Not yet recruiting
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213
Charity Ruhl, 412-647-2013, ruhlcl@upmc.edu
- Recruiting
Skin Cancer and Dermatology Institute
Reno, Nevada, 89509
Jennifer Craddock, 775-336-3665, Jdiaz@skincancerderm.com
- Recruiting
Integrative Skin Science and Research
Sacramento, California, 95815
Sydney Fong, 916-524-1216, recruitment@integrativeresearch.com
- Recruiting
Progressive Clinical Research, PA
San Antonio, Texas, 78213
Jamie Renker, 210-614-5557, jrenker@progclin.com
- Not yet recruiting
Georgia Skin & Cancer Center
Savannah, Georgia, 31406
Dr. Sidney Smith, 912-925-0067, sidney.smith@elligodirect.com
- Not yet recruiting
Endeavor Health
Skokie, Illinois, 60077
Karla Radillo Mendoza, 847-663-8530, karla.radillomendoza@endeavorhealth.com
- Not yet recruiting
NMC Research LLC
Tampa, Florida, 33614
Dr Thomas M Taylor, 813-374-0568, Researchteam@nmc-research.com
- Not yet recruiting
Valiance Clinical Research - Tarzana
Tarzana, California, 91356
Jesse Padilla, 213-880-1730, j.padilla@valianceclinicalresearch.com
- Recruiting
Paradigm Clinical Research Centers, LLC: Wheat Ridge
Wheat Ridge, Colorado, 80033
Cassandra Clayton, 303-463-1947, cclayton@paradigm-research.com
Poland14 sites, 14 recruiting
- Not yet recruiting
NZOZ Centrum Medyczne KERmed
Bydgoszcz
- Not yet recruiting
OptiTrial
Chojnice
- Not yet recruiting
Dermedea Clinic
Gdansk
- Not yet recruiting
CM Pratia Katowice
Katowice
- Not yet recruiting
Provita Sp. z o. o.
Katowice
- Not yet recruiting
Klinika Zdybski - Dermedic (Kielce)
Kielce
- Not yet recruiting
Clinical Best Solution Sp. z o.o.
Lublin
- Not yet recruiting
NZOZ Hipokrates
Piotrkow Trybunalski
- Not yet recruiting
Twoja Przychodnia Poznanskie Centrum Medyczne Sp.
Poznan
- Not yet recruiting
Laser Clinic S.C. Andrzej Krolicki, Tomasz Kochanowski
Szczecin
- Not yet recruiting
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Szczecin
- Not yet recruiting
Klinika Ambroziak Dermatologia
Warsaw
- Not yet recruiting
Medicus Clinic
Wroclaw
- Not yet recruiting
Softskin Medical Center Dr Elzbieta Wojtowicz-Prus
Wroclaw
Canada9 sites, 9 recruiting
- Not yet recruiting
Beacon Dermatology
Calgary, Alberta
- Not yet recruiting
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Calgary, Alberta
- Recruiting
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta
Angela Tycholaz, 5874095160, tycholaza@rejuv.ca
- Recruiting
Rejuvenation Dermatology Clinic Edmonton South
Edmonton, Alberta
Angela Tycholaz, 5877604265, tycholaza@rejuv.ca
- Recruiting
DermEdge Research
Mississauga, Ontario
Mark Lomaga, +1 905 274 9999, drlomaga@dermedge.com
- Recruiting
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan
Kyle Cullingham, +1 306-373-0040, kcullingham@nosm.ca
- Recruiting
Centre de Recherche Saint-Louis (Sherbrooke)
Sherbrooke, Quebec
Evelyn Chinchilla, 1-888-728-9142, eachinchilla@recherchestlouis.com
- Not yet recruiting
FACET Dermatology
Toronto, Ontario
- Recruiting
North York Research Inc.
Toronto, Ontario
North York Research Inc., 416-222-7546, maryam@bnderm.com
Germany7 sites, 7 recruiting
- Not yet recruiting
Fachklinik Bad Bentheim
Bad Bentheim
- Not yet recruiting
University Hospital Dresden
Dresden
- Not yet recruiting
Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie
Frankfurt
- Not yet recruiting
Dermatologikum Hamburg GmbH
Hamburg
- Not yet recruiting
University of Luebeck
Lübeck
- Not yet recruiting
University Hospital of Muenster
Münster
- Not yet recruiting
Hautarztpraxis Dr. Hoffmann
Witten
Czechia6 sites, 6 recruiting
- Not yet recruiting
CCR Ostrava s.r.o.
Ostrava
- Not yet recruiting
Pratia Pardubice a.s.
Pardubice
- Not yet recruiting
Clintrial s.r.o.
Prague
- Not yet recruiting
Fakultni Nemocnice Kralovske Vinohrady
Prague
- Not yet recruiting
Praglandia s.r.o.
Prague
- Not yet recruiting
Pratia Prague
Prague
Hungary6 sites, 6 recruiting
- Not yet recruiting
Trial Pharma Kft.
Békéscsaba
- Not yet recruiting
Dept. Dermatology, Venereology and Dermatooncology, Semmelweis University
Budapest
- Not yet recruiting
Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)
Debrecen
- Not yet recruiting
Pecsi Tudomanyegyetem
Pécs
- Not yet recruiting
Komplex Labor Kft
Szeged
- Not yet recruiting
University of Szeged
Szeged
Bulgaria5 sites, 5 recruiting
- Not yet recruiting
Medical Center Medconsult Burgas EOOD
Burgas
- Not yet recruiting
Medical Center Kazanlak EOOD
Kazanlak
- Not yet recruiting
Medical Center Medconsult Pleven-Lovech Branch
Lovech
- Not yet recruiting
Medical Center Medconsult Pleven OOD
Pleven
- Not yet recruiting
Medical Centre Pratia Clinic EOOD
Varna
Spain5 sites, 5 recruiting
- Not yet recruiting
Hospital General Universitario Dr. Balmis
Alicante
- Not yet recruiting
Hospital Universitari Germans Trias i Pujol
Badalona
- Not yet recruiting
Hospital Universitario La Paz
La Paz
- Not yet recruiting
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela
- Not yet recruiting
Hospital Universitario Miguel Servet
Zaragoza
About this study
Official title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis
This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study.
Read the detailed description
This study contains two parts: Part 1 and Part 2.
Part 1 (24-Week Placebo-controlled Period):
Eligible patients will be randomized in a 1:1:1:1 ratio to receive either camoteskimab dose 1, camoteskimab dose 2, camoteskimab dose 3 or placebo.
Part 2 (Extension Period):
In part 2, all participants will receive camoteskimab.
This study will enroll both treatment-naive participants and those with an inadequate response to previous biologic therapy.
- Conditions
- Atopic Dermatitis, Atopic, Dermatitis, Dermatitis, Atopic, Dermatologic Disease, Eczema
- 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
Drug Product
PlaceboDrug
Inactive substance
| Study group | Role | What they receive |
|---|---|---|
| Camoteskimab Dose Level 1 | Experimental | Camoteskimab administered subcutaneously Receives: Drug: Camoteskimab |
| Camoteskimab Dose Level 2 | Experimental | Camoteskimab administered subcutaneously Receives: Drug: Camoteskimab |
| Camoteskimab Dose Level 3 | Experimental | Camoteskimab administered subcutaneously Receives: Drug: Camoteskimab |
| Placebo | Placebo comparator | Dummy version of the study drug administered subcutaneously 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 24
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: From Baseline visit until Week 24 visit
Secondary outcomes (3)
Proportion of participants achieving at least 75% improvement from baseline in EASI (EASI-75)
To further assess the efficacy of camoteskimab in participants with moderate-to-severe AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
Measured: 24 weeks
Proportion of participants with vIGA-AD 0/1 and a decrease in vIGA-AD of ≥ 2 points from baseline
To further assess the efficacy of camoteskimab in participants with moderate-to-severe AD via Validated Investigator's Global Assessment Scale, which provides a global clinical assessment of AD severity
Measured: 24 weeks
Proportion of participants with an improvement of ≥ 4 or more points from baseline in peak pruritus NRS (PP-NRS) weekly average of the daily scores
To further assess the efficacy of camoteskimab in participants with moderate-to-severe AD via the Peak Pruritus Numerical Rating Scale, which assesses itch severity.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start28 May 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Apr 2028 (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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apollo Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599813
- Sponsor's protocol ID
- AP43CP04
- Status last verified
- Aug 2026
- First submitted
- 15 May 2026
- Last updated
- 28 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07599813
- Acronym / sponsor ID
- AP43CP04
- Conditions
- Atopic Dermatitis, Atopic, Dermatitis, Dermatitis, Atopic, Dermatologic Disease, Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Apollo Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 28 May 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 20 May 2026 (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 2b, multicenter, randomized, double-blind, placebo-controlled study.
Detailed description
This study contains two parts: Part 1 and Part 2.
Part 1 (24-Week Placebo-controlled Period):
Eligible patients will be randomized in a 1:1:1:1 ratio to receive either camoteskimab dose 1, camoteskimab dose 2, camoteskimab dose 3 or placebo.
Part 2 (Extension Period):
In part 2, all participants will receive camoteskimab.
This study will enroll both treatment-naive participants and those with an inadequate response to previous biologic therapy.
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 |
|---|---|---|
| Camoteskimab Dose Level 1 | Experimental | Drug: CamoteskimabCamoteskimab administered subcutaneously |
| Camoteskimab Dose Level 2 | Experimental | Drug: CamoteskimabCamoteskimab administered subcutaneously |
| Camoteskimab Dose Level 3 | Experimental | Drug: CamoteskimabCamoteskimab administered subcutaneously |
| Placebo | Placebo comparator | Drug: PlaceboDummy version of the study drug administered subcutaneously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-65 inclusive, at the time of signing the informed consent.
- Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria.
- Participants with moderate-to-severe AD defined by:
- Participants who are candidates for systemic therapy, defined as history of inadequate response to topical AD treatments applied for at least 28 days, or for the maximum duration recommended by the product prescribing information, or for treatment with topical AD treatments is medically inadvisable due to important side effects or safety risks.
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Key exclusion criteria (35 listed)
- History or other evidence of severe illness or any other conditions such as psychiatric illness, severe depression or previous history of suicidal attempt in past 10 years that would render the participant, in the opinion of the Investigator, unsuitable for the study.
- Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline.
- 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 based on the Investigator's judgement.
- Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator.
- Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma) based on investigator judgement.
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-9109Drug Product | Drug | Camoteskimab Dose Level 1, Camoteskimab Dose Level 2, Camoteskimab Dose Level 3 |
| PlaceboInactive substance | Drug | Placebo |
Primary outcome
Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 24
Time frame: From Baseline visit until Week 24 visit
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.
3 secondary outcomes
Proportion of participants achieving at least 75% improvement from baseline in EASI (EASI-75)
Time frame: 24 weeks
Proportion of participants with vIGA-AD 0/1 and a decrease in vIGA-AD of ≥ 2 points from baseline
Time frame: 24 weeks
Proportion of participants with an improvement of ≥ 4 or more points from baseline in peak pruritus NRS (PP-NRS) weekly average of the daily scores
Time frame: 24 weeks
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 28 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.
85 sites in 8 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 85 sites in 8 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 10 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 28 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 85 sites in United States, Poland, Canada, Germany, Czechia and 3 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 24 (time frame: From Baseline visit until Week 24 visit). 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 28 Aug 2026.