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Tests treatment safety and results for Active Rheumatoid Arthritis
Official title A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
ClinicalTrials.gov ID: NCT07409103
What this study is testing
What is ELV001 25 mg?
ELV001 25 mg is an investigational medicine, being studied as a potential treatment for active rheumatoid arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 2 randomized, double-blind, placebo-controlled study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit. Approximately 180 participants are planned to be enrolled.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Provided written informed consent to participate to the study and are able and willing to adhere to the study protocol.
- Male or female, 18 to 75 years of age, at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 and 32.0 kg/m2 and minimum weight of 50 kg at the Screening Visit.
- Have a diagnosis of adult onset RA and fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)...
- Have active RA defined by a DAS28-CRP ≥ 3.2 and the presence of ≥ 3 swollen joints (based on 66 joint count) and ≥ 3 tender joints (based on 68 joint...
You likely can't join if
- Class IV RA according to ACR revised response criteria.
- Have been treated with more than 1 previous bDMARDs or tsDMARDs, excluding the current TNFi.
- Has a secondary non-response to the TNFi due to anti-drug antibodies, as assessed by the Investigator.
- Have a dose change of MTX or TNFi within the last 3 months before Baseline, or a dose change of hydroxychloroquine or oral prednisolone within the...
- Have oral prednisone \> 7.5 mg/day equivalent or parenteral corticosteroids within the last 4 weeks before Baseline.
- Have intra-articular corticosteroids within the last 4 weeks before Baseline.
See the full eligibility criteria
Who can join
- Provided written informed consent to participate to the study and are able and willing to adhere to the study protocol.
- Male or female, 18 to 75 years of age, at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 and 32.0 kg/m2 and minimum weight of 50 kg at the Screening Visit.
- Have a diagnosis of adult onset RA and fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (Aletaha et al. 2010) for at least 6 months prior to...
- Have active RA defined by a DAS28-CRP ≥ 3.2 and the presence of ≥ 3 swollen joints (based on 66 joint count) and ≥ 3 tender joints (based on 68 joint count) at Screening and Baseline. The distal interphalangeal joint...
- Have C-reactive protein (CRP) ≥ upper limit of normal (ULN) at Screening.
- Have adequate hematologic function at Screening AND at Baseline.
- Have adequate liver and renal function at Screening.
- Are currently treated with MTX (methotrexate) with folic acid supplementation according to local standard-of-care. The maximum dose of MTX is 25 mg/week for oral use and 20 mg/week for parenteral use. The minimum dose...
- Are currently treated with a TNFi for at least 6 months, of which at least 3 months at a stable dose. Participants should have demonstrated a partial response to the TNFi, as evidenced by the Investigator or treating...
- The following therapies for RA are permitted during the study, if the dose is stable for ≥ 4 weeks prior to Screening: hydroxychloroquine up to 400 mg/day, oral prednisone ≤ 7.5 mg daily or equivalent corticosteroid...
- Female participants of childbearing potential must:
- Have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to first dosing.
- Use highly effective contraception from signing the informed consent until at least 90 days after the last dosing.
- Not donate ova from signing the informed consent until at least 90 days after the last dosing.
- Male participants must use condoms and partners of childbearing potential must use highly effective contraception until at least 90 days after the last dosing. Male participants must not donate sperm until at least 90...
What rules you out
- Class IV RA according to ACR revised response criteria.
- Have been treated with more than 1 previous bDMARDs or tsDMARDs, excluding the current TNFi.
- Has a secondary non-response to the TNFi due to anti-drug antibodies, as assessed by the Investigator.
- Have a dose change of MTX or TNFi within the last 3 months before Baseline, or a dose change of hydroxychloroquine or oral prednisolone within the last 4 weeks before Baseline.
- Have oral prednisone \> 7.5 mg/day equivalent or parenteral corticosteroids within the last 4 weeks before Baseline.
- Have intra-articular corticosteroids within the last 4 weeks before Baseline.
- Had any other csDMARD, bDMARD, or immunosuppressive drug in the last 2 months.
- Had any cell depletion therapy (eg, rituximab) in the last 12 months.
- Have QT interval corrected for heart rate (QTc) using Fridericia's correction (QTcF) \> 450 ms for males or QTcF \> 470 ms for females either at Screening or Baseline, based on safety 12-lead electrocardiogram (ECG)...
- Have evidence of interstitial lung disease (ILD) based on either medical history, clinical signs and symptoms, imaging and/or lung function test, independently of the etiology of the ILD.
- Have a condition which could interfere with drug absorption including but not limited to short bowel syndrome.
- Have presence of 1 or more significant concurrent medical conditions, which could interfere with the treatment and/or the study per Investigator judgment, including but not limited to the following: poorly controlled...
- Have a history of chronic alcohol abuse, IV drug abuse or illicit drug abuse within 1 year before Screening.
- Have a diagnosis or history of malignant disease, with the exceptions of basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Have had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to Screening, or any planned surgical procedure scheduled to...
- Have received a Bacillus Calmette-Guerin (BCG) vaccination or BCG treatment within 12 months of Screening; or received any other live vaccine(s) (ie, live attenuated) within 3 months of Screening, or intend to receive a...
- Have had any of the following types of infection within 3 months of Screening or develops any of these infections before the randomization visit:
- Serious (requiring hospitalization, and/or parenteral antibiotic treatment),
- Opportunistic, as defined in (Winthrop et al. 2015) (note, Herpes zoster infection is considered active and ongoing until all vesicles are dry and crusted over),
- Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer),
- Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis). Participants with recurrent nonserious infections such as cellulitis and uncomplicated orolabial...
- Have any of the following:
- Human immunodeficiency virus (HIV) infection,
- Current infection with hepatitis B virus (HBV) (ie, positive for hepatitis B surface antigen and/or polymerase chain reaction [PCR] positive for HBV DNA),
- Current infection with hepatitis C virus (HCV) (ie, positive for HCV RNA),
- Active tuberculosis (TB).
- Have or have had latent TB infection (LTBI) that has not been treated with a complete course of appropriate therapy as defined by the World Health Organization (WHO) and/or the United States Centers for Disease Control...
- Current or recent acute active infection (ie, participants must have had no symptoms and/or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment within 30 days of...
- Any other concurrent severe and/or uncontrolled medical, surgical or psychiatric and/or social condition which, in the view of the Investigator, could compromise the participant's safety or ability to participate in the...
- Use of other investigational medicinal products within 12 weeks or at least 5 half-lives (whichever is longer) before study drug administration.
- Women who are pregnant or breast-feeding or planning to become pregnant during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Glendale, Arizona, United States
- Tucson, Arizona, United States
- Tustin, California, United States
- Denver, Colorado, United States
- Boca Raton, Florida, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- South Miami, Florida, United States
- Lake Charles, Louisiana, United States
- Lansing, Michigan, United States
- Charlotte, North Carolina, United States
- Wilmington, North Carolina, United States
- Duncansville, Pennsylvania, United States
- Wyomissing, Pennsylvania, United States
- Baytown, Texas, United States
- Houston, Texas, United States
- Jackson, Texas, United States
- Red Oak, Texas, United States
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Glendale, Arizona, United States; Tucson, Arizona, United States; Tustin, California, United States; Denver, Colorado, United States; Boca Raton, Florida, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.