A Phase 1 interventional study of LFD-200 and Placebo in Rheumatoid Arthritis, sponsored by Lifordi Immunotherapeutics, Inc.. Recruiting at 10 sites in 5 countries. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Lifordi Immunotherapeutics, Inc. · Phase 1, Interventional, and Treatment
This is a double-blind, randomized, placebo- and active-controlled study investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) doses of LFD-200. The study design includes: a single ascending dose (SAD) study in up to 66 adult healthy participants (HPs) to investigate the effects of a single SC dose, with a 30-day follow-up; a multiple ascending dose (MAD) study in up to 40 HPs to assess up to 4 weekly SC doses, with a 30-day follow-up after the last dose; and a MAD study in up to 70 participants with moderate to severe rheumatoid arthritis (RA) to evaluate up to 13 weekly SC doses, with a 30-day follow-up after the last dose.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 176 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →This is the only study on the registry with Lifordi Immunotherapeutics, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Healthy Participants:
Exclusion Criteria for Healthy Participants:
Any of the following lab abnormalities:
Inclusion Criteria for RA Participants:
Has active RA disease defined as follows:
Exclusion Criteria for RA Participants:
abnormalities on per the Investigator or Sponsor or any of the following mean ECG parameters on screening/baseline (triplicate) ECG:
Use or anticipated use of medications for the timeframes specified below:
The presence at Screening of any laboratory values of concern in the opinion of the Investigator or Sponsor or of any of the below based on central laboratory testing at Screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Three planned cohorts (SAD HP Cohorts 1 to 3) and 3 optional cohorts (SAD HP Cohorts 4 to-6) of 11 participants each will receive a single SC dose of LFD-200, a single SC dose of matching saline placebo, or a single oral dose of open label 10 mg prednisone. Within each cohort, 6 participants will be randomly assigned to receive LFD-200, 2 participants will receive saline placebo, and 3 will receive prednisone.
Drug: LFD-200 · Other: Placebo · Drug: Oral Prednisone
Two planned cohorts (MAD HP Cohorts 1 and 2) of 8 HPs each (16 total) will be randomly assigned to receive 4 weekly SC doses of LFD-200 (6 participants) or saline placebo (2 participants) over a duration of 22 days.
Drug: LFD-200 · Other: Placebo
Two planned cohorts (MAD RA Cohorts 1 and 2) of 14 RA participants each (28 total) will be randomly assigned to receive either up to 13 weekly SC doses of LFD-200 over 85 days with a daily prednisone placebo tablet (LFD-200 arm; 8 participants), or up to 13 weekly SC doses of saline placebo over 85 days with daily prednisone placebo tablet (placebo arm; 3 participants), or up to 13 weekly SC doses of saline placebo over 85 days with a daily dose of oral prednisone (prednisone arm; 3 participants)
Drug: LFD-200 · Other: Placebo · Drug: Oral Prednisone
2 mL glass vials, as 150 mg/mL concentrated solution
0.9% NaCl
Tablet
Placebo tablet to match Prednisone
Incidence of Adverse Events (AEs)
Number of participants experiencing any adverse events during the study period.
Time frame: Baseline up to 30 days after last dose.
Severity of Adverse Events (AEs)
Classification of adverse events based on severity (mild, moderate, severe).
Time frame: Baseline up to 30 days after last dose.
Seriousness of Adverse Events (AEs)
Number of participants experiencing serious adverse events (SAEs) during the study period.
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in Blood Pressure (BP)
Difference in systolic and diastolic blood pressure measurements from baseline to specified time points.
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in Temperature
Difference in body temperature measurements from baseline to specified time points.
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in Respiratory Rate
Difference in respiratory rate measurements from baseline to specified time points.
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in Heart Rate (HR)
Difference in heart rate measurements from baseline to specified time points.
Time frame: Baseline up to 30 days after last dose.
Change in Hemeglobin from Baseline to specified timepoints
Hemeglobin is measured in g/dL
Time frame: Baseline up to 30 days after last dose.
Change in Alanine Aminotransferase from Baseline to specified timepoints
Alanine Aminotransferase is measured in U/L
Time frame: Baseline up to 30 days after last dose.
Change in Leukocytes in urine from Baseline to specified timepoints
Leukocytes in urine is measured in x10\^6/L
Time frame: Baseline up to 30 days after last dose.
Change in Heart Rate (HR) from Baseline to specified timepoints
Heart rate is measured in beats per minute
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in PR Interval
Difference in PR interval measurements from baseline to specified time points.
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in QRS Interval
Difference in QRS interval measurements from baseline to specified time points.
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in QT Interval
Difference in QT interval measurements from baseline to specified time points.
Time frame: Baseline up to 30 days after last dose.
Primary Outcome Measure: Change from Baseline in QTcF Interval
Difference in QTcF interval measurements from baseline to specified time points.
Time frame: Baseline up to 30 days after last dose.
Incidence of Clinical Findings on Physical Examination
Number of participants with clinical findings during physical examinations, including injection site reactions.
Time frame: Baseline up to 30 days after last dose.
Severity of Clinical Findings on Physical Examination
Classification of clinical findings based on severity (mild, moderate, severe), including injection site reactions.
Time frame: Baseline up to 30 days after last dose.
Maximum Observed Plasma Concentration (Cmax)
The highest concentration of the drug observed in plasma after administration.
Time frame: Baseline up to 30 days after last dose.
Trough Concentration (Ctrough)
The lowest concentration of the drug observed in plasma before the next dose.
Time frame: Baseline up to 30 days after last dose.
Average Concentration (Cavg)
The average concentration of the drug in plasma over a specified time period
Time frame: Baseline up to 30 days after last dose.
Clearance
The rate at which the drug is removed from the body.
Time frame: Baseline up to 30 days after last dose.
Volume of Distribution
The volume in which the drug is distributed in the body.
Time frame: Baseline up to 30 days after last dose.
Area Under the Plasma Concentration vs. Time Curve from Time Zero to the Last Quantifiable Concentration (AUClast)
The area under the plasma concentration-time curve from the time of dosing to the last measurable concentration.
Time frame: Baseline up to 30 days after last dose.
Area Under the Plasma Concentration vs. Time Curve from Time Zero Extrapolated to Infinity (AUCinf)
The area under the plasma concentration-time curve from the time of dosing extrapolated to infinity.
Time frame: Baseline up to 30 days after last dose.
Area Under the Plasma Concentration vs. Time Curve from Time Zero to 168 Hours Post-Dose (AUC0-168)
The area under the plasma concentration-time curve from the time of dosing to 168 hours post-dose.
Time frame: Baseline up to 30 days after last dose.
Area Under the Plasma Concentration vs Time Curve Over the Dosing Interval (AUCtau)
The area under the plasma concentration-time curve over the dosing interval.
Time frame: Baseline up to 30 days after last dose.
Accumulation Ratio (Rac)
The ratio of drug accumulation in plasma after multiple dosing compared to a single dose.
Time frame: Baseline up to 30 days after last dose.
Time Corresponding to the Maximum Observed Plasma Concentration (Tmax)
The time at which the maximum plasma concentration of the drug is observed.
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in Cortisol Levels
Difference in cortisol levels from baseline to specified time points.
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in Bone Biomarkers
Difference in Bone Biomarker levels from baseline to specified time points
Time frame: Baseline up to 30 days after last dose.
Change from Baseline in DAS28-CRP
Difference in Disease Activity Score 28 - C-reactive protein (DAS28-CRP) from baseline to specified time points for rheumatoid arthritis (RA) cohorts.
Time frame: Baseline up to 30 days after last dose.
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Jul 2027, 21 months after the start.
Of 128 industry-sponsored phase 1 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 21 months is above that.
Counting every sponsor, half of 148 studies reached it within 16 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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