A Study to Evaluate Camoteskimab in Participants With Still's Disease (NCT04752371) | Clinical Trial Compass
TerminatedPhase 1
A Study to Evaluate Camoteskimab in Participants With Still's Disease
Stopped: Sponsor discretion
United States, Belgium, Poland5 participantsStarted 2021-03-25
Plain-language summary
The main purpose of the study is to evaluate the safety and tolerability of Camoteskimab in participants with Still's Disease.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subject is 18 to 75 years of age (inclusive) at the time of consent. The date of signature of the informed consent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the Screening Visit (Visit 1).
✓. Subject has been diagnosed with AOSD based on classification criteria (according to Yamaguchi et al, 1992) defined as having 5 or more of the following criteria, 2 of which are major:
✓. Subject has reported a recurring fever \>38°C, consistent with active disease, within the last 5 days of the Screening and Baseline Visits.
✓. If undergoing treatment with non-steroidal anti-inflammatory drugs (NSAID), subject is on a stable dose for at least 48 hours prior to the Baseline Visit (Visit 2).
✓. If undergoing treatment with glucocorticoids, subject is on a stable dose for at least 48 hours prior to the Baseline Visit (Visit 2).
✓. If undergoing treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs), subject is on a stable dose for at least 4 weeks prior to the Baseline Visit (Visit 2).
✓. For subjects who have received treatment with biological DMARDs, subject has the required washout (normalization) period prior to the Baseline Visit (Visit 2).
✓. Anakinra - 1 week
Exclusion criteria
✕. Subject is, in the opinion of the investigator, mentally or legally incapacitated, or has significant emotional problems at the time of the Screening Visit (Visit 1) that could interfere with the subject's participation or cooperation with the conduct of study evaluations
What they're measuring
1
Incidence of AEs
Timeframe: Baseline to Week 24
2
Incidence of Clinically Significant Changes from Baseline in Vital Signs
Timeframe: Baseline to Week 24
3
Incidence of Clinically Significant Changes from Baseline in Clinical Laboratory Results
✕. Subject has a chronic severe or uncontrolled medical disorder that might confound the results of safety assessments conducted in the study in the opinion of the Investigator or Medical Monitor.
✕. Subject has another serious chronic-inflammatory disease.
✕. Subject has a relevant, active infection or another disease, which entails a tendency towards infection.
✕. Subject has active macrophage activation syndrome.
✕. Subject has a history of unresolved latent tuberculosis.