A Study to Evaluate AEVI-007 in Participants With Adult Onset Still's Disease

• Status: Recruiting
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study is to evaluate the safety and tolerability of AEVI-007 in participants with Adult Onset Still's Disease (AOSD).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cerecor Inc

Criteria

Inclusion Criteria:

1. Participant is 18 to 75 years of age (inclusive) at the time of consent.

2. Participant 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:

1. Major Criteria

• Fever >39°C, lasting 1 week or longer

• Arthralgia or arthritis, lasting 2 weeks or longer

• Typical rash

• Leukocytes >10,000 mm^3 with >80% polymorphonuclear cells

2. Minor Criteria

• Sore throat

• Recent development of significant lymphadenopathy

• Hepatomegaly or splenomegaly

• Abnormal liver function tests

• Negative tests for antinuclear antibody and rheumatoid factor

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

4. If undergoing treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), participant is on a stable dose for at least 48 hours prior to the Baseline Visit (Visit 2).

5. If undergoing treatment with glucocorticoids, participant is on a stable dose for at least 48 hours prior to the Baseline Visit (Visit 2).

6. If undergoing treatment with conventional disease-modifying antirheumatic drugs (DMARDs), participant is on a stable dose for at least 4 weeks prior to the Baseline Visit (Visit 2).

7. For participants who have received treatment with biological DMARDs, participant has the required washout (normalization) period prior to the Baseline Visit (Visit 2). The washout (normalization) period for biological DMARDs is as follows:

1. Anakinra - 1 week

2. Etanercept, rilonacept - 4 weeks

3. Adalimumab, certolizumab, infliximab, golimumab, abatacept, tocilizumab and canakinumab - 8 weeks

4. Rituximab - 36 weeks

Exclusion Criteria:

1. Participant has another serious chronic-inflammatory disease.

2. Participant has a relevant, active infection or another disease, which entails a tendency towards infection.

3. Participant has active macrophage activation syndrome.

4. Participant has the following abnormal values:

1. Serum creatinine concentration >1.5 mg/dl.

2. Hemoglobin ≤ 10 g/dl, neutrophils ≤1,500 /μl and/or thrombocytes ≤75,000 /μl.