A Study of the Effects of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis

Apollo Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis; Eczema Atopic Dermatitis; Eczema, Atopic; Dermatitis; Atopic; Dermatologic Disease; Eczema

Treatments: Drug: Placebo; Drug: Camoteskimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06436183

AP43CP03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants must be 18-75 years of age inclusive, at the time of signing the informed consent.

2. Chronic AD for at least 1 year.

3. Participants with moderate to severe AD defined by:

   1. 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.
   2. AD involvement of ≥ 10% body surface area (BSA) at Baseline.
   3. EASI score of ≥ 12 at Baseline.
   4. Pruritus numerical rating scale (NRS) ≥ 4 at Baseline.

4. 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.

5. 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.

6. Participant provides signed informed consent.

Exclusion criteria

1. 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:

   1. Dupilumab, tralokinumab, lebrikizumab within 8 weeks prior to Baseline.
   2. Systemic JAKi within 4 weeks prior to Baseline.
   3. 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.

2. 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.

3. Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma).

4. 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.

5. 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.

6. 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.

7. 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

8. 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.

9. Has had previous exposure to anti-IL-18 therapy.

10. Treatment with any investigational agent, or any investigational device or procedure, within 28 days (or 5 half- lives, whichever is greater) of screening.

11. Has any of the following laboratory findings

    1. Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2.
    2. Hemoglobin ≤8 g/dL.
    3. Neutrophils ≤1,500/μL.
    4. Platelets ≤75,000/μL.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Dose 1

Experimental group

Description:

Camoteskimab

Treatment:

Drug: Camoteskimab

Dose 2

Experimental group

Description:

Camoteskimab

Treatment:

Drug: Camoteskimab

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Dummy version of the study drug

Treatment:

Drug: Placebo