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Monoclonal Antibodies

Cohort 1: Camoteskimab 7 mg/kg for Adult Onset Still's Disease

Phase 1
Waitlist Available
Led By Isabelle Peene, MD, PhD
Research Sponsored by Cerecor Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 4 and week 12
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for people with AOSD.

Eligible Conditions
  • Adult Onset Still's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 4 and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 4 and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of AEs
Incidence of Clinically Significant Changes from Baseline in Clinical Laboratory Results
Incidence of Clinically Significant Changes from Baseline in Vital Signs
Secondary outcome measures
Change from Baseline in CRP, ferritin, and ESR
Change from Baseline in the Disease Activity Score-28 with C-Reactive Protein (DAS28-CRP)
Change from Baseline in the Patient Global Assessment of Disease Activity
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: Camoteskimab Dose escalation/reductionExperimental Treatment1 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/kgExperimental Treatment1 Intervention
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 Location

Who is running the clinical trial?

Cerecor IncLead Sponsor
8 Previous Clinical Trials
1,907 Total Patients Enrolled
Avalo Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
1,921 Total Patients Enrolled
Apollo Therapeutics LtdLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have signed up to partake in this experiment?

"This investigation necessitates the involvement of 12 compliant patients, who meet specific enrollment criteria. Two potential sites where study participation is accepted are Triwest Research Associates in El Cajon, California and University of Florida's Division of Rheumatology in Columbia, Maryland."

Answered by AI

Am I eligible to join the experiment?

"This clinical trial is seeking twelve individuals suffering from adult-onset Still's disease within the ages of 18 and 75. Successful applicants must meet these conditions to be accepted into the study."

Answered by AI

Does this trial include elderly individuals in its recruitment process?

"According to the guidelines, individuals aged 18 and above but below 75 can be included in this medical trial."

Answered by AI

Is enrollment for this study currently open to participants?

"Affirmative. The clinicaltrials.gov portal states that this ongoing medical trial, initially posted on March 25th 2021, is actively seeking participants. There needs to be 12 individuals recruited from 10 different sites for the study's completion."

Answered by AI

Has the FDA approved AEVI-007 (CERC-007, AVTX-007)?

"Our team at Power gave AEVI-007 (CERC-007, AVTX-007) a ranking of 1 on the safety scale because this is an early clinical trial; there exists only limited evidence to suggest that it is both safe and effective."

Answered by AI

How many sites are administering this clinical research?

"Currently, this clinical trial is enrolling patients across 10 sites. These locations include El Cajon, Columbia and La Mesa in addition to 7 other cities. To reduce travel needs during the study period, it is suggested that you select the nearest clinic for your participation."

Answered by AI
~1 spots leftby Mar 2025