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Tests treatment safety and results for Rheumatoid Arthritis (RA)
Official title Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
ClinicalTrials.gov ID: NCT06628206
What this study is testing
What is LPX-TI641?
LPX-TI641 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for rheumatoid arthritis (ra).
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
- The goal of this clinical trial is to study the drug LPX-TI641 in patients with rheumatoid arthritis and psoriatic arthritis. We will compare the safety and tolerability of LPX-TI641 to placebo that contains no drug.
- Phase 1: an early, usually small safety study
- 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 and older
You may be able to join if
- Subject has signed an Informed Consent Form (ICF) prior to any study-specific procedures being performed
- ≥ 18 years old, irrespective of their race and ethnicity.
- Body Mass Index (BMI) 18.0-35.0 kg/m2, inclusive, at screening.
- Participants are willing and able to adhere to study protocol requirements including but not limited to scheduled outpatient visits, inpatient...
- A. Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for...
You likely can't join if
- Any subject who meets any of the following criteria will not qualify for entry into the study:
- History of clinically significant medical conditions or any other reason that in the opinion of the PI would interfere with subject's participation...
- History of clinically significant per the PI's opinion drug or alcohol abuse within the last 6 months
- Pregnant or lactating women or women currently undergoing infertility treatments or women who intend to become pregnant during the time of study...
- Any known history of malignancy within 5 years other than other than completely treated non-metastatic basal cell carcinomas or squamous cell...
- Any known history of a rheumatologic, autoimmune or cutaneous disease other than RA (except secondary Sjögren\'s syndrome), or PSA.
See the full eligibility criteria
Who can join
- Subject has signed an Informed Consent Form (ICF) prior to any study-specific procedures being performed
- ≥ 18 years old, irrespective of their race and ethnicity.
- Body Mass Index (BMI) 18.0-35.0 kg/m2, inclusive, at screening.
- Participants are willing and able to adhere to study protocol requirements including but not limited to scheduled outpatient visits, inpatient hospital stay, laboratory tests, and 12-lead ECGs.
- A. Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA at least 3 months prior to screening AND Active disease defined by...
- The subject must be judged to be in good health by the investigator to participate in the study, based on clinical evaluations, including laboratory safety tests, medical history, physical examination, vital signs and...
- Female subject is postmenopausal (at least 1 year; to be confirmed by follicle stimulating hormone (FSH) if less than 2 years since last menstrual period), permanently sterilized (e.g. tubal occlusion, hysterectomy...
- Oral
- Intravaginal
- Transdermal
- Injectable vi. Progestogen-only hormone contraception (oral or injectable) is associated with inhibition of ovulation. vii. Vasectomized partner viii. Sexual abstinence -this is considered a highly effective method only...
- Negative serum B-human chorionic gonadotropin test at screening (for all females) and negative urine pregnancy at randomization (Day 1) (females of childbearing potential) prior to administration of investigational...
What rules you out
- Any subject who meets any of the following criteria will not qualify for entry into the study:
- History of clinically significant medical conditions or any other reason that in the opinion of the PI would interfere with subject's participation in this study
- History of clinically significant per the PI's opinion drug or alcohol abuse within the last 6 months
- Pregnant or lactating women or women currently undergoing infertility treatments or women who intend to become pregnant during the time of study enrollment.
- Any known history of malignancy within 5 years other than other than completely treated non-metastatic basal cell carcinomas or squamous cell carcinomas of the skin or localized carcinoma in situ of the cervix.
- Any known history of a rheumatologic, autoimmune or cutaneous disease other than RA (except secondary Sjögren\'s syndrome), or PSA.
- Significant systemic involvement secondary to RA/PsA (active vasculitis, pulmonary fibrosis, or Felty\'s syndrome).
- Currently have non-plaque forms of psoriasis e.g. erythrodermic, guttate or pustular with the exception of nail psoriasis which is allowed.
- Receipt of an investigational therapy less than 3 months or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study
- Receipt of any of the following excluded therapies: Any cell depleting therapy including but limited to anti-CD4, anti-CD5, anti-CD3, rituximab, ocrelizumab, or ofatumumab. Have received prior tsDMARDs including but not...
- Lack of response to \> 1 therapeutic agent targeting tumor necrosis factor.
- If on prednisone, subject must be on stable dose, not to exceed equivalent of 10mg of prednisone per day (RA and PsA), and dose must be stable for ≥ 4 weeks prior to Day 1. No injected corticosteroids 8 weeks prior to...
- Use of psoriasis treatments:
- Oral or topical retinoids 2 weeks prior to Day 1 and throughout the study
- Topical treatments (steroids, or JAK inhibitors) within 2 weeks prior to Day 1 and throughout the study
- PUVA or UVB phototherapy within 4 weeks prior to Day 1 and throughout the study.
- No high potency opioid analgesics 2 weeks prior to baseline and during study. Analgesic dose must remain stable throughout from screening through completion of the study.
- COVID-19: The subject has COVID-19 positive status (confirmed by clinical signs and symptoms and a positive SARS-CoV-2 NAAT or rapid antigen COVID test) at any time during the screening period. OR has had recent...
- Subject has clinical or laboratory evidence of active or latent tuberculosis (TB) infection at screening as assessed by QuantiFERON-TB-Gold or a purified protein derivative skin test or equivalent (or both if required...
- Any active or recurrent infection within the past 4 weeks prior to screening requiring IV or oral antibiotics.
- Laboratory values of the following at the Screening Visit: Hemoglobin \ 2.0 x the upper limit of normal (ULN) or bilirubin \>= ULN; Bilirubin \>ULN Serum creatinine \> 1.5 x the ULN; Platelets \< 100,000 cells/[mm\^3]...
- Acutely worsened renal function within past 3 months prior to screening or estimated creatinine clearance \<60ml/min by CKD-EPI creatinine equation
- Participants with a history of active or latent TB will be excluded from the study, unless documentation of complete TB treatment, consistent with local country guidelines, can be provided.
- Subject has any clinically significant finding on 12-lead ECG at screening or admission. NOTE: QTc(F) interval of \>450 msec in male participants or \>470 msec in female participants will be the basis for exclusion from...
- Subject with positive results for HBsAg (hepatitis B surface antigens) and/or HBcAb (Hepatitis B core antibodies) and/or HCV Ab (hepatitis C antibodies), and/or HIV Ab (human immunodeficiency virus antibodies).
- Blood loss of \>250 mL or donated blood within 56 days or donated plasma within 7 days of screening.
- Recent vaccination with live attenuated vaccines such as influenza, measles, mumps, and rubella (MMR), Herpes zoster, varicella, yellow fever, Rotavirus vaccine, etc., or inactivated vaccines such as Hepatitis A, rabies...
- History of infection 1) requiring hospitalization or parenteral antimicrobial therapy within 3 months prior to Day 1 or 2) treated with oral antimicrobial therapy within 2 weeks prior to Day 1.
- Subject is investigative site personnel, sponsor personnel, or a member of their immediate families (spouse, parent, child or sibling whether biological or legally adopted).
The study team makes the final eligibility decision.
Where it's taking place
- Amman, Jordan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amman, Jordan. 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.