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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04752371
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Avalo Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Isabelle Peene, MD, PhD
Principal Investigator Affiliation University Hospital, Ghent
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Poland, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Adult Onset Still's Disease
Arms & Interventions

Arms

Experimental: Cohort 1: AEVI-007 7 mg/kg

6 participants will be administered AEVI-007 at a dose of 7 mg/kg (500 mg maximum) at Baseline, Week 4 and Week 8. Based on safety results in first 6 participants, additional participants may be enrolled in this cohort.

Experimental: Cohort 2: AEVI-007 Dose escalation/reduction

Based on safety results in Cohort 1, 6 participants will be administered AEVI-007 at a dose of 14 mg/kg (1000 mg maximum) at Baseline, Week 4 and Week 8, or may receive a lower dose (4 mg/kg, maximum 300 mg). Dose in participants receiving 14 mg/kg may be reduced based on safety results.

Interventions

Drug: - AEVI-007 (CERC-007, AVTX-007)

Intravenous (IV) Infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sponsor Investigative Site, La Mesa, California

Status

Recruiting

Address

Sponsor Investigative Site

La Mesa, California, 91942

Sponsor Investigative Site, San Diego, California

Status

Recruiting

Address

Sponsor Investigative Site

San Diego, California, 92108

Sponsor Investigative Site, Gainesville, Florida

Status

Recruiting

Address

Sponsor Investigative Site

Gainesville, Florida, 32610

Sponsor Investigative Site, Columbia, Maryland

Status

Withdrawn

Address

Sponsor Investigative Site

Columbia, Maryland, 21046

Sponsor Investigative Site, Ann Arbor, Michigan

Status

Recruiting

Address

Sponsor Investigative Site

Ann Arbor, Michigan, 48109

International Sites

Sponsor Investigative Site, Gent, Oost-Vlaanderen, Belgium

Status

Recruiting

Address

Sponsor Investigative Site

Gent, Oost-Vlaanderen, 9000

Sponsor Investigative Site, Elbląg, Poland

Status

Recruiting

Address

Sponsor Investigative Site

Elbląg, , 82-300

Sponsor Investigative Site, Pomorskie, Poland

Status

Recruiting

Address

Sponsor Investigative Site

Pomorskie, , 85-168

Sponsor Investigative Site, Poznań, Poland

Status

Recruiting

Address

Sponsor Investigative Site

Poznań, , 61-113

Sponsor Investigative Site, Poznań, Poland

Status

Recruiting

Address

Sponsor Investigative Site

Poznań, , 61-545

Sponsor Investigative Site, Kyiv, Ukraine

Status

Active, not recruiting

Address

Sponsor Investigative Site

Kyiv, , 03151

Sponsor Investigative Site, Poltava, Ukraine

Status

Active, not recruiting

Address

Sponsor Investigative Site

Poltava, , 36011

Sponsor Investigative Site, Ternopil', Ukraine

Status

Active, not recruiting

Address

Sponsor Investigative Site

Ternopil', , 46002

Sponsor Investigative Site, Vinnitsa, Ukraine

Status

Active, not recruiting

Address

Sponsor Investigative Site

Vinnitsa, , 21018