BridgeMD
New treatment option for Atopic Dermatitis
Official title A Phase 2b Study of the Effects of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT07599813
What this study is testing
What is Camoteskimab?
Camoteskimab is an investigational medicine, being studied as a potential treatment for atopic dermatitis.
Also referred to as APL-9109.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- History or other evidence of severe illness or any other conditions such as psychiatric illness, severe depression or previous history of suicidal...
- Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before...
- Participant has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or...
- 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...
- Any clinically significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically significant...
See the full eligibility criteria
Who can 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.
- 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...
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participant provides signed informed consent
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Bryant, Arkansas, United States
- Huntington Beach, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- Sacramento, California, United States
- Tarzana, California, United States
- Wheat Ridge, Colorado, United States
- Cape Coral, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- North Lauderdale, Florida, United States
- North Miami Beach, Florida, United States
- Tampa, Florida, United States
- Savannah, Georgia, United States
- Meridian, Idaho, United States
- Skokie, Illinois, United States
- Clarksville, Indiana, United States
- Columbus, Indiana, United States
+ 51 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Bryant, Arkansas, United States; Huntington Beach, California, United States; Los Angeles, California, United States; Northridge, California, United States and 65 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.