Camoteskimab for Still's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Camoteskimab (also known as AEVI-007) for individuals with Still's Disease, a rare inflammatory condition causing symptoms like high fevers and joint pain. The primary goal is to determine if Camoteskimab is safe and tolerable for these patients. Participants will receive the treatment at set intervals, with doses adjusted based on initial results. Ideal candidates have experienced recurring high fevers and have managed their condition with stable doses of certain medications. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
You may need to stop certain medications before joining the trial. If you're taking biological DMARDs, there is a required period without them before starting the trial, ranging from 1 to 36 weeks depending on the specific medication. For NSAIDs, glucocorticoids, and conventional DMARDs, you must be on a stable dose for a certain period before the trial.
Is there any evidence suggesting that Camoteskimab is likely to be safe for humans?
Research has shown that Camoteskimab, the treatment under study, is a lab-made protein known as a monoclonal antibody. These proteins can attach to specific targets in the body. Camoteskimab targets IL-18, a molecule in the immune system.
Previous studies have examined the safety of Camoteskimab in people. These studies found that it is generally well-tolerated, with few serious side effects. However, since this study is in an early phase, it primarily focuses on safety and how the body processes the treatment. Although earlier research is promising, the main goal is to learn more about the safety of Camoteskimab for treating Still's Disease.12345Why do researchers think this study treatment might be promising?
Researchers are excited about camoteskimab for Still's disease because it offers a novel approach by targeting specific immune pathways involved in the condition. Unlike traditional treatments like NSAIDs or corticosteroids, which broadly suppress inflammation, camoteskimab works by modulating the immune system more precisely, potentially reducing side effects. This targeted action could make camoteskimab an effective alternative for patients who don't respond well to existing therapies. Additionally, the ability to adjust the dosage based on patient response could optimize treatment outcomes and further minimize risks.
What evidence suggests that Camoteskimab might be an effective treatment for Still's Disease?
Research has shown that camoteskimab has potential in treating conditions like atopic dermatitis. In studies, patients using camoteskimab showed significant improvements in their EASI scores, which measure eczema severity. This suggests that camoteskimab might help reduce inflammation. In this trial, participants will receive camoteskimab in different dosing regimens to evaluate its effectiveness. Although direct evidence for its effectiveness in treating Still's Disease is not yet available, camoteskimab's ability to reduce inflammation could be beneficial. The treatment blocks IL-18, a protein involved in the immune system, which might help calm the overactive immune response seen in Still's Disease.56789
Who Is on the Research Team?
Isabelle Peene, MD, PhD
Principal Investigator
University Hospital, Ghent
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Camoteskimab at Baseline, Week 4, and Week 8
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AEVI-007
- Camoteskimab
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Cohort 2 dose will be determined based on a review of Cohort 1 data. 6 participants will be administered camoteskimab at the determined dose at Baseline, Week 4, and Week 8.
6 participants will be administered camoteskimab at a dose of 7 mg/kg (500 mg maximum) at Baseline, Week 4, and Week 8.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cerecor Inc
Lead Sponsor
Avalo Therapeutics, Inc.
Lead Sponsor
Apollo Therapeutics Ltd
Lead Sponsor
Citations
NCT06436183 | A Study of the Effects of Camoteskimab in ...
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension to evaluate the efficacy and safety of ...
2.
apollotx.com
apollotx.com/news/apollo-therapeutics-anti-il-18-antibody-camoteskimab-met-the-primary-endpoint/Apollo Therapeutics' Anti-IL-18 Antibody Camoteskimab ...
Patients receiving camoteskimab had a clinically meaningful and statistically significant reduction in mean EASI score at week 16 compared ...
3.
hcplive.com
hcplive.com/view/camoteskimab-primary-endpoint-phase-2a-clinical-trial-atopic-dermatitisCamoteskimab Meets Primary Endpoint in Phase 2a ...
Patients with atopic dermatitis treated with camoteskimab saw significant reductions in their mean EASI score at Week 16 compared to ...
Progress in Biological Therapies for Adult-Onset Still's Disease
So far, the efficacy of sarilumab in AOSD was reported only in one patient who was successfully treated after developing resistance to TCZ. The ...
5.
businessweekly.co.uk
businessweekly.co.uk/posts/no-camouflaging-success-of-apollo-therapeutics-atopic-dermatitis-chameleon-trialNo camouflaging success of Apollo Therapeutics' atopic ...
The double-blind, randomised, placebo-controlled trial (n=62) demonstrated clinically meaningful efficacy, achieving a statistically significant ...
Material Safety Data Sheet of Camoteskimab
Material Safety Data Sheet of Camoteskimab contains identification of substance and details of the supplier of the safety data sheet.
7.
medchemexpress.com
medchemexpress.com/camoteskimab.html?srsltid=AfmBOopGiNmJxEuywdui09aIwSuF0adGDmAv4X7CnBWgb06C7rhzbeXfCamoteskimab (AVTX-007) | Anti-IL-18 mAb
Camoteskimab (AVTX-007) is an anti-IL-18 monoclonal antibody with fully humanized, high-affinity. Camoteskimab specifically binds IL-18 and blocks the ...
Human IL-18 Antibody - Camoteskimab Biosimilar
Highly pure Anti-hIL-18-hIgG1-FES is a biosimilar antibody of Camoteskimab that blocks IL-18 signaling. Functionally tested. Effectorless IgG1.
Apollo Therapeutics - Camoteskimab - AdisInsight - Springer
Camoteskimab (formerly AVTX 007/CERC 007/AEVI 007/MEDI 2338) is a high affinity, fully human anti interleukin-18 (IL-18) monoclonal antibody, ...
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