A Study to Evaluate Camoteskimab in Participants With Still's Disease

Recruiting at 19 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

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new medication called Camoteskimab to see if it is safe and well-tolerated in people with Still's Disease.

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.

How is the drug AEVI-007, Camoteskimab different from other treatments?

AEVI-007, Camoteskimab is unique because it targets Ca2+/calmodulin-dependent protein kinase II (CaMKII), which plays a critical role in the growth and aggressive behavior of certain cancers like osteosarcoma and lung cancer. This mechanism of action is different from many standard treatments, offering a novel approach by potentially inhibiting tumor growth and reducing cancer cell proliferation. ^{1 2 3 4 5}

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. China pubmed.ncbi.nlm.nih.gov

[Inhibiting effect of CaMKIIN up-regulation on leukemia cells growth and its mechanism]. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Cationic CaMKII Inhibiting Nanoparticles Prevent Allergic Asthma. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

alpha-CaMKII controls the growth of human osteosarcoma by regulating cell cycle progression. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Ca2+/calmodulin-dependent protein kinase IIγ enhances stem-like traits and tumorigenicity of lung cancer cells. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Alpha-CaMKII plays a critical role in determining the aggressive behavior of human osteosarcoma. [2021]