Camoteskimab for Still's Disease

No longer recruiting at 23 trial locations

Overseen By Michael Weinreich

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cerecor Inc

Must be taking: NSAIDs, Glucocorticoids, DMARDs

Disqualifiers: Chronic inflammatory disease, Active infection, Neoplasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

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. ^{1 2 3 4 5}

Why 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. ^{5 6 7 8 9}

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

Participant has reported a recurring fever >38°C, consistent with active disease, within the last 5 days of the Screening and Baseline visits.

Anakinra - 1 week

Elevated IL-18

Exclusion Criteria

Participant has another serious chronic-inflammatory disease.

Participant has active macrophage activation syndrome

Participant has the following abnormal values:

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Camoteskimab at Baseline, Week 4, and Week 8

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AEVI-007
• Camoteskimab

How Is the Trial Designed?

Group I: Cohort 2: Camoteskimab Dose escalation/reduction Experimental Treatment 1 Intervention

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.

Group II: Cohort 1: Camoteskimab 7 mg/kg Experimental Treatment 1 Intervention

6 participants will be administered camoteskimab at a dose of 7 mg/kg (500 mg maximum) at Baseline, Week 4, and Week 8.

Who Is Running the Clinical Trial?

Cerecor Inc

Lead Sponsor

Trials

9

Recruited

1,900+

Avalo Therapeutics, Inc.

Lead Sponsor

Trials

13

Recruited

2,100+

Apollo Therapeutics Ltd

Lead Sponsor

Trials

5

Recruited

330+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06436183

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-dermatitis

Camoteskimab 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9038152/

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-trial

No camouflaging success of Apollo Therapeutics' atopic ... The double-blind, randomised, placebo-controlled trial (n=62) demonstrated clinically meaningful efficacy, achieving a statistically significant ...

6. abmole.com abmole.com/literature/camoteskimab-msds.html?srsltid=AfmBOoo1lK6uXL_lODhaWukcHs6RHbr9zFqAAXiHhXbAiI6xcHvNMfnR

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=AfmBOopGiNmJxEuywdui09aIwSuF0adGDmAv4X7CnBWgb06C7rhzbeXf

Camoteskimab (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 ...

8. invivogen.com invivogen.com/anti-human-il-18-camoteskimab-biosimilar-antibody

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.

9. adisinsight.springer.com adisinsight.springer.com/drugs/800033948

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, ...