Adult Onset Still's DiseasePhase 1NCT04752371
A Study to Evaluate Camoteskimab in Participants With Still's Disease
A Phase 1 study testing Camoteskimab (CERC-007, AVTX-007, AEVI-007) in people with Adult Onset Still's Disease, run by Apollo Therapeutics Ltd at 11 sites in 4 countries.
Trial summary
The main purpose of the study is to evaluate the safety and tolerability of Camoteskimab in participants with Still's Disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adult Onset Still's Disease
- What is being tested?
- Camoteskimab (CERC-007, AVTX-007, AEVI-007)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 25 Mar 2021to 24 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Major Criteria i. Fever >39°C, lasting 1 week or longer ii. Arthralgia or arthritis, lasting 2 weeks or longer iii. Typical rash iv. Leukocytes >10,000 mm3 with >80% polymorphonuclear cells b. Minor Criteria i. Sore throat ii. Recent development of significant lymphadenopathy iii. Hepatomegaly or splenomegaly iv. Abnormal liver function tests v. Negative tests for antinuclear antibody and rheumatoid factor
- 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).
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- 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).
- The washout (normalization) period for biological DMARDs is as follows:
- Anakinra - 1 week
- Etanercept, rilonacept - 4 weeks
- Adalimumab, certolizumab, infliximab, golimumab, abatacept, tocilizumab and canakinumab - 8 weeks
- Rituximab - 36 weeks
- Non-pregnant female subjects of childbearing potential who are heterosexually active and non-sterile male subjects with female sexual partners of childbearing potential agree to use a highly effective method of contraception during treatment and for 25 weeks following the last dose of investigational product. A highly effective method of birth control is defined as one that results in a low failure rate (ie, <1% per year) when used consistently and correctly, such as oral/injectable/inserted/implanted/transdermal contraceptives, intrauterine hormone-releasing system or intrauterine device (IUD), or sexual abstinence. Contraception is not required where at least 6 weeks has passed since sterilization, defined as females having undergone one of the following surgeries: hysterectomy, bilateral tubal ligation or occlusion, bilateral oophorectomy, or bilateral salpingectomy; and males who are vasectomized. Contraception is also not required where females are postmenopausal (defined as 12 consecutive months of spontaneous amenorrhea and age ≥51 years). Females of reproductive potential must have a negative pregnancy test as part of the screening/baseline assessment.
- Subject has provided written informed consent for this study.
- Subject is willing and able to comply with the protocol.
Who cannot join
- 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
- 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.
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- Subject has the following abnormal values:
- Serum creatinine concentration >1.5 mg/dl.
- Hemoglobin ≤ 10 g/dl, neutrophils ≤1,500/μl and/or thrombocytes ≤75,000/μl.
- Subject has a history of neoplasia with the exception of a curatively treated non-melanoma skin tumor or carcinoma of the cervix treated in situ without any indication of recurrence within the last 10 years.
- Subject has received a vaccination with a live vaccine within 12 weeks prior to the Baseline Visit (Visit 2).
- Subject has used an investigational product or been enrolled in a clinical study including vaccines within 30 days of the Screening Visit (Visit 1).
- Subject has known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any ingredients of the investigational product.
- Subject is pregnant or is breastfeeding and will not abstain from breastfeeding during participation in the study and for 25 weeks post last dose of investigational product.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Poland4 sites
Sponsor Investigative Site
Elblag, 82-300
Sponsor Investigative Site
Pomorskie, 85-168
Sponsor Investigative Site
Poznan, 61-113
Sponsor Investigative Site
Poznan, 61-545
Ukraine4 sites
Sponsor Investigative Site
Kyiv, 03151
Sponsor Investigative Site
Poltava, 36011
Sponsor Investigative Site
Ternopil, 46002
Sponsor Investigative Site
Vinnitsa, 21018
United States2 sites
Sponsor Investigative Site
Ann Arbor, Michigan, 48109
Sponsor Investigative Site
Gainesville, Florida, 32610
About this study
Official title: A Phase 1b, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Camoteskimab in Subjects With Adult Onset Still's Disease
The main purpose of the study is to evaluate the safety and tolerability of Camoteskimab in participants with Still's Disease.
- Conditions
- Adult Onset Still's Disease
- Being tested
- Camoteskimab (CERC-007, AVTX-007, AEVI-007)
- Keywords
- Adult Onset Still's Disease, AEVI-007, Camoteskimab, IL-18, sJIA
- Medical subject headings
- Still's Disease, Adult-Onset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camoteskimab (CERC-007, AVTX-007, AEVI-007)Drug
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Camoteskimab 7 mg/kg | Experimental | 6 participants will be administered camoteskimab at a dose of 7 mg/kg (500 mg maximum) at Baseline, Week 4, and Week 8. Receives: Drug: Camoteskimab (CERC-007, AVTX-007, AEVI-007) |
| Cohort 2: Camoteskimab Dose escalation/reduction | Experimental | 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. Receives: Drug: Camoteskimab (CERC-007, AVTX-007, AEVI-007) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs
Measured: Baseline to Week 24
Incidence of Clinically Significant Changes from Baseline in Vital Signs
Measured: Baseline to Week 24
Incidence of Clinically Significant Changes from Baseline in Clinical Laboratory Results
Measured: Baseline to Week 24
Secondary outcomes (8)
Proportion of subjects who achieved absence of fever
Fever defined as no temperature > 38 degrees Celcius for 48 hours
Measured: Baseline to Week 24
Proportion of subjects whose C-Reactive Protein (CRP) Levels Reduced by 50% or more from Baseline
Measured: Baseline to Week 4 and Week 12
Change from Baseline in the Physician Global Assessment of Disease Activity
Physician global assessment of disease activity will be assessed using a Visual Analogue Scale (VAS) where 0 mm indicates no evidence of disease and 100 mm indicates very severe disease activity.
Measured: Baseline to Week 4 and Week 12
Change from Baseline in the Patient Global Assessment of Disease Activity
Patient global assessment of disease activity will be assessed using a Visual Analogue Scale (VAS) where 0 mm indicates no evidence of disease and 100 mm indicates very severe disease activity.
Measured: Baseline to Week 4 and Week 12
Change from Baseline in the modified Pouchot score
Measured: Baseline to Week 4 and Week 12
Change from Baseline in the Disease Activity Score-28 with C-Reactive Protein (DAS28-CRP)
Measured: Baseline to Week 4 and Week 12
Change from Baseline in CRP, ferritin, and ESR
Measured: Baseline to Week 4 and Week 12
Serum Concentration of camoteskimab
Measured: Baseline through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start25 Mar 2021
- Primary completion24 May 2022
- Study completion24 May 2022
Why it stopped: Sponsor discretion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Onset Still's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apollo Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752371
- Sponsor's protocol ID
- AEVI-007-AOSD-101
- Other IDs
- 2020-004099-16
- Status last verified
- Aug 2023
- First submitted
- 9 Feb 2021
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Camoteskimab in Subjects With Adult Onset Still's Disease
- ClinicalTrials.gov ID
- NCT04752371
- Acronym / sponsor ID
- AEVI-007-AOSD-101
- Conditions
- Adult Onset Still's Disease
- Keywords
- Adult Onset Still's Disease, AEVI-007, Camoteskimab, IL-18, sJIA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor discretion
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Apollo Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to evaluate the safety and tolerability of Camoteskimab in participants with Still's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Camoteskimab 7 mg/kg | Experimental | Drug: Camoteskimab (CERC-007, AVTX-007, AEVI-007)6 participants will be administered camoteskimab at a dose of 7 mg/kg (500 mg maximum) at Baseline, Week 4, and Week 8. |
| Cohort 2: Camoteskimab Dose escalation/reduction | Experimental | Drug: Camoteskimab (CERC-007, AVTX-007, AEVI-007)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camoteskimab (CERC-007, AVTX-007, AEVI-007)Intravenous (IV) Infusion | Drug | Cohort 1: Camoteskimab 7 mg/kg, Cohort 2: Camoteskimab Dose escalation/reduction |
Primary outcome
Incidence of AEs
Time frame: Baseline to Week 24
Incidence of Clinically Significant Changes from Baseline in Vital Signs
Time frame: Baseline to Week 24
Incidence of Clinically Significant Changes from Baseline in Clinical Laboratory Results
Time frame: Baseline to Week 24
8 secondary outcomes
Proportion of subjects who achieved absence of fever
Time frame: Baseline to Week 24
Proportion of subjects whose C-Reactive Protein (CRP) Levels Reduced by 50% or more from Baseline
Time frame: Baseline to Week 4 and Week 12
Change from Baseline in the Physician Global Assessment of Disease Activity
Time frame: Baseline to Week 4 and Week 12
Change from Baseline in the Patient Global Assessment of Disease Activity
Time frame: Baseline to Week 4 and Week 12
Change from Baseline in the modified Pouchot score
Time frame: Baseline to Week 4 and Week 12
Change from Baseline in the Disease Activity Score-28 with C-Reactive Protein (DAS28-CRP)
Time frame: Baseline to Week 4 and Week 12
Change from Baseline in CRP, ferritin, and ESR
Time frame: Baseline to Week 4 and Week 12
Serum Concentration of camoteskimab
Time frame: Baseline through Week 24
Results and safety
The study was stopped early (reason given: Sponsor discretion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Camoteskimab (CERC-007, AVTX-007, AEVI-007) in people with Adult Onset Still's Disease, run by Apollo Therapeutics Ltd at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland, Ukraine, United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor discretion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs (time frame: Baseline to Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.