Systemic Lupus ErythematosusPhase 1NCT03878303
Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing AC0058TA in people with Systemic Lupus Erythematosus, run by ACEA Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 1b, double blind, randomized, placebo-controlled study of the safety and tolerability, pharmacokinetics and pharmacodynamics of AC0058TA in patients with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- AC0058TA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2018to Dec 2021
- 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
- Clinical diagnosis of SLE according to ACR 1997 criteria or 2009 SLE-SLICC criteria with ANA positive (≥ 1:40) patients who could receive hydroxychloroquine and/or steroids treatment.
- Adequate hematopoietic function, including:
- Platelet count > 75 × 10^9/L
- Leukocyte ≥ 2.0 × 10^9/L including CD19+ B cell counts of at least 50/μL
- Hemoglobin ≥ 10 g/dL
- Adequate liver function
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- Bilirubin: < 1.2 X upper limit of normal (ULN)
- AST: < 1.2 X upper limit of normal (ULN)
- ALT: < 1.2 X upper limit of normal (ULN)
- Adequate renal function:
- BUN and creatinine:< 1.5 X upper limit of normal (ULN)
- Female of reproductive potential must agree to use two forms of contraception during screening, during the study, and for at least 30 days after the last dose of AC0058TA.
- Able to provide written informed consent in accordance with federal, local, and institutional guidelines.
Who cannot join
- Active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis) or active bleeding disorder within 60 days prior to the first day of study treatment.
- Clinical evidence of significant unstable or uncontrolled acute or chronic diseases other than SLE which, in the opinion of the investigator, could confound the results of the study, put the patient at undue risk, or interferes with protocol adherence, or a subject's ability to give informed consent.
- History or presence of congestive heart failure (New York Heart Association [NYHA]Class III to IV), symptomatic ischemia, clinically significant conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to the first day of study treatment.
- Have severe lupus complications (Acute Lupus Pneumonitis, Diffuse Alveolar Hemorrhage, Chronic Interstitial Pneumonia, Pulmonary Hypertension, Pulmonary Embolism) severe lupus gastrointestinal diseases (Lupus Mesenteric Vasculitis, Protein-Losing Enteropathy, Pancreatitis, Intestinal Pseudo-Obstruction).
- History of any bleeding disorder secondary to SLE.
- Have active, severe lupus kidney disease WHO III-V (Rapidly Progressive Glomerulonephritis, Nephrotic Syndrome, Renal Tubular Acidosis, Renal Insufficiency), proteinuria > 500 mg/day.
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- Acute or chronic infections requiring systemic antibiotic, antifungal, or antiviral therapy within 60 days of the first day of study treatment.
- Known HIV infection or positive for hepatitis B virus infection (HBsAg positive, HBeAg, HBeAb or HBcAb positive and HBV DNA positive) or hepatitis C antibody positive (HCV RNA positive).
- Primary immunodeficiency other than complement deficiencies.
- Active or latent tuberculosis within 6 months prior to the first day of study treatment.
- Receipt of a live-attenuated vaccine within 2 months prior to screening.
- Within 2 weeks prior to screening：Use of injectable corticosteroids.
- Within 2 months prior to screening: use of abatacept, anti-tumor necrosis factor alpha agents, intravenous immunoglobulin, plasmapheresis, mycophenolate, MTX and leflunomide or therapies not otherwise specified in protocol.
- Use of cyclophosphamide or chlorambucil within five half-lives of screening.
- Use of rituximab, belimumab, or any other B cell-depleting or modulating therapies within 6 months of screening.
- Female patients who are pregnant or breastfeeding.
- Use of an investigational therapeutics within 30 days or 5 half-lives prior to screening, whichever is greater.
- Has a positive pregnancy test result at Screening or Check-in (females only).
- Women with childbearing potential are defined as all women who are physiologically able to have a pregnancy, unless they are using an efficient contraceptive method during treatment and within 30 days after discontinuation of treatment as below.
- Complete abstinence (if this is in line with the subject's preferred and usual lifestyle). Periodic abstinence (e.g., calendaring method, ovulation method, symptomatic body temperature method, post-ovulation method) and in vitro ejaculation are unacceptable contraceptive methods.
- Patients who have received female sterilization (bilateral ovariectomy with or without hysterectomy) or tubal ligation for at least 6 weeks prior to study treatment. In case of only unilateral ovariectomy, female fertility status must be confirmed by follow-up assessment of hormone levels.
- Combination of the following two methods:
- Intrauterine device (IUD) or intrauterine system (IUS).
- Barrier contraceptive methods: condoms or cervical cap (diaphragm or cervical cap) coated with spermicidal foam/gel/cream/vaginal suppositories. If women use oral contraceptives only, they should use the same contraceptives at a stable dose for at least 3 months before starting the study treatment.
- If women have at least 12 months of natural amenorrhea and are clinically compatible (e.g., at the corresponding age, with a history of vasomotor symptoms or received bilateral ovariectomy with or without hysterectomy, they are regarded as postmenopausal women with no childbearing potential. In case of only unilateral ovariectomy, female fertility status must be confirmed by follow-up assessment of hormone levels before the women can be considered to have no childbearing potential.
- Men who have sexual intercourse unless they use a condom during sexual intercourse and must not donate sperm from the first dose of study drug until 30 days after discontinuation of treatment and do not impregnate their sexual partners during the period. Vasectomized males are also required to use condoms to prevent the transmission of drugs through semen.
- Subject who, in the opinion of the Investigator, should not participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Metroplex Clinical Research Center
Dallas, Texas, 75231
Roy Fleischmann, MD MACR
About this study
Official title: A Phase 1b Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Pharmacokinetics and Pharmacodynamics of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)
This is a Phase 1b, double blind, randomized, placebo-controlled study of the safety and tolerability, pharmacokinetics and pharmacodynamics of AC0058TA in patients with systemic lupus erythematosus (SLE).
Read the detailed description
The study will be performed in adult patients with autoantibody (ANA) positive SLE, as defined by the American College of Rheumatology (ACR) 1997 criteria or System Lupus International Collaborating Clinic (SLICC) 2009 criteria who are receiving standard of care therapy for SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- AC0058TA, Placebo AC0058TA
- Keywords
- SLE
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC0058TADrug
Also called AC0058
25 mg capsules
Placebo AC0058TADrug
Also called Placebo
equivalent dose of investigational product
| Study group | Role | What they receive |
|---|---|---|
| AC0058TA | Experimental | AC0058TA will be administered in 25 mg capsules orally at the following doses: 50 mg QD, 100 mg QD, 200 mg QD and 100 mg BID Receives: Drug: AC0058TA |
| Placebo AC0058TA | Placebo comparator | Placebo AC0058TA will be administered orally at the equivalent dose of investigational product Receives: Drug: Placebo AC0058TA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Measured: Measured up to 12 weeks
Secondary outcomes (3)
Maximum Plasma Concentration and Area Under the Curve
Measured: Measured on Day 1, Day 28, and Day 84
Pharmacodynamics of AC0058TA: Bruton's tyrosine kinase (BTK) occupancy (% occupancy)
Measured: Measured on Day 1, Day 28, and Day 84
Pharmacodynamics of AC0058TA: serum antidsDNA antibodies, ANAs, complement (C3 and C4) and B-cell markers
Measured: Measured on Day 1, Day 28, and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start28 Nov 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ACEA Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hangzhou ACEA Pharmaceutical Research Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Roy Fleischmann, MD MACR, Principal investigator, Metroplex Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878303
- Sponsor's protocol ID
- AC00582017-101
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Pharmacokinetics and Pharmacodynamics of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT03878303
- Acronym / sponsor ID
- AC00582017-101
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- ACEA Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hangzhou ACEA Pharmaceutical Research Co., Ltd.
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Mar 2019 (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.
This is a Phase 1b, double blind, randomized, placebo-controlled study of the safety and tolerability, pharmacokinetics and pharmacodynamics of AC0058TA in patients with systemic lupus erythematosus (SLE).
Detailed description
The study will be performed in adult patients with autoantibody (ANA) positive SLE, as defined by the American College of Rheumatology (ACR) 1997 criteria or System Lupus International Collaborating Clinic (SLICC) 2009 criteria who are receiving standard of care therapy for SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC0058TA | Experimental | Drug: AC0058TAAC0058TA will be administered in 25 mg capsules orally at the following doses: 50 mg QD, 100 mg QD, 200 mg QD and 100 mg BID |
| Placebo AC0058TA | Placebo comparator | Drug: Placebo AC0058TAPlacebo AC0058TA will be administered orally at the equivalent dose of investigational product |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Clinical diagnosis of SLE according to ACR 1997 criteria or 2009 SLE-SLICC criteria with ANA positive (≥ 1:40) patients who could receive hydroxychloroquine and/or steroids treatment.
- Adequate hematopoietic function, including:
- Adequate liver function
- Adequate renal function:
- Female of reproductive potential must agree to use two forms of contraception during screening, during the study, and for at least 30 days after the last dose of AC0058TA.
Key exclusion criteria (27 listed)
- Active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis) or active bleeding disorder within 60 days prior to the first day of study treatment.
- Clinical evidence of significant unstable or uncontrolled acute or chronic diseases other than SLE which, in the opinion of the investigator, could confound the results of the study, put the patient at undue risk, or interferes with protocol adherence, or a subject's ability to give informed consent.
- History or presence of congestive heart failure (New York Heart Association [NYHA]Class III to IV), symptomatic ischemia, clinically significant conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to the first day of study treatment.
- Have severe lupus complications (Acute Lupus Pneumonitis, Diffuse Alveolar Hemorrhage, Chronic Interstitial Pneumonia, Pulmonary Hypertension, Pulmonary Embolism) severe lupus gastrointestinal diseases (Lupus Mesenteric Vasculitis, Protein-Losing Enteropathy, Pancreatitis, Intestinal Pseudo-Obstruction).
- History of any bleeding disorder secondary to SLE.
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 |
|---|---|---|
| AC0058TAAlso: AC005825 mg capsules | Drug | AC0058TA |
| Placebo AC0058TAAlso: Placeboequivalent dose of investigational product | Drug | Placebo AC0058TA |
Primary outcome
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame: Measured up to 12 weeks
3 secondary outcomes
Maximum Plasma Concentration and Area Under the Curve
Time frame: Measured on Day 1, Day 28, and Day 84
Pharmacodynamics of AC0058TA: Bruton's tyrosine kinase (BTK) occupancy (% occupancy)
Time frame: Measured on Day 1, Day 28, and Day 84
Pharmacodynamics of AC0058TA: serum antidsDNA antibodies, ANAs, complement (C3 and C4) and B-cell markers
Time frame: Measured on Day 1, Day 28, and Day 84
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
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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.
Roy Fleischmann, MD MACR principal investigator
Metroplex Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AC0058TA in people with Systemic Lupus Erythematosus, run by ACEA Therapeutics, Inc. at 1 site in United States.
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 13 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liming Liu, MD, PhD (1-858-249-9120, limingliu@aceatherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events (time frame: Measured up to 12 weeks). 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 18 Mar 2019.