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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
  • 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

    Recruiting
  • Trail Horizon

    Clifton, New Jersey, 07013

    Chirag Patel, 732-798-0301, cpatel@trialhorizon.com

    Not yet 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

    Recruiting
  • University of California Los Angeles

    Los Angeles, California, 90095

    Hamiya Askaryar, 424-365-4129, haskaryar@mednet.ucla.edu

    Not yet 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

    Recruiting
  • Eminent Clinical Research and Associates

    North Lauderdale, Florida, 33068

    Marie Moore, 954-366-5373, admin@eminentclinicalresearch.com

    Not yet 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

    Recruiting
  • UPMC Department of Dermatology

    Pittsburgh, Pennsylvania, 15213

    Charity Ruhl, 412-647-2013, ruhlcl@upmc.edu

    Not yet 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

    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

    Not yet recruiting
  • Paradigm Clinical Research Centers, LLC: Wheat Ridge

    Wheat Ridge, Colorado, 80033

    Cassandra Clayton, 303-463-1947, cclayton@paradigm-research.com

    Recruiting

Other trials in United States

Poland14 sites, 14 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

    Not yet recruiting

Other trials in Poland

Canada9 sites, 9 recruiting
  • Beacon Dermatology

    Calgary, Alberta

    Not yet recruiting
  • Laser Rejuvenation Clinics Edmonton D.T. Inc.

    Calgary, Alberta

    Not yet 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

    Recruiting
  • FACET Dermatology

    Toronto, Ontario

    Not yet recruiting
  • North York Research Inc.

    Toronto, Ontario

    North York Research Inc., 416-222-7546, maryam@bnderm.com

    Recruiting

Other trials in Canada

Germany7 sites, 7 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

    Not yet recruiting

Other trials in Germany

Czechia6 sites, 6 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

    Not yet recruiting

Other trials in Czechia

Hungary6 sites, 6 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

    Not yet recruiting

Other trials in Hungary

Bulgaria5 sites, 5 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

    Not yet recruiting

Other trials in Bulgaria

Spain5 sites, 5 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

    Not yet recruiting

Other trials in Spain

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.

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 groups in NCT07599813
Study groupRoleWhat they receive
Camoteskimab Dose Level 1ExperimentalCamoteskimab administered subcutaneously
Receives: Drug: Camoteskimab
Camoteskimab Dose Level 2ExperimentalCamoteskimab administered subcutaneously
Receives: Drug: Camoteskimab
Camoteskimab Dose Level 3ExperimentalCamoteskimab administered subcutaneously
Receives: Drug: Camoteskimab
PlaceboPlacebo comparatorDummy 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted20 May 2026
  2. Study start28 May 2026
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion30 Apr 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
280 participants (estimated)
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

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.

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