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Tests treatment safety and results for Muscle Atrophy
Official title Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.
ClinicalTrials.gov ID: NCT05211986
What this study is testing
What is IMM01-STEM?
IMM01-STEM is an investigational medicine, given as an once-weekly injection into a muscle, being studied as a potential treatment for muscle atrophy.
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
- An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Has moderate KOA (defined as Kellgren-Lawrence [KL] grade 2 to 3) on affected limb
- Has quadriceps weakness (\<7.5N/kg)
- Can ambulate \>50 feet unassisted
- This criteria deleted with protocol amendment 6
- Has a body mass index (BMI) of \<40kg/m2
You likely can't join if
- Severe KOA (defined as KL grade \>3) on contralateral limb
- Has had prior total knee arthroplasty
- Has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this...
- Has current or past history of malignancy (5y) excluding nonmelanoma skin cancer
- Has neurological, vascular, or cardiac condition that limit function, or, in the opinion of the investigator, could jeopardize or would compromise...
- Has uncontrolled comorbidities including diabetes (hemoglobin A1c level \>7.0%), Hypertension (resting heart rate \>100 bpm, systolic blood pressure...
See the full eligibility criteria
- Has moderate KOA (defined as Kellgren-Lawrence [KL] grade 2 to 3) on affected limb
- Has quadriceps weakness (\<7.5N/kg)
- Can ambulate \>50 feet unassisted
- This criteria deleted with protocol amendment 6
- Has a body mass index (BMI) of \<40kg/m2
- A male must agree to use contraception during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.
- A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP). OR
- A WOCBP who agrees to follow the protocol's contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment.
- Female has a negative pregnancy test result at screening and prior to investigational medicinal product (IMP) administration
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
- Willing and able to comply with all study requirements, according to the judgment of the Investigator
- Has discontinued systemic oral or intravenous steroid use for 6 months prior to Screening
- Has vital sign measurements within the following ranges at Baseline (predose at Visit 2): heart rate \>50 and \ 100 and \ 50 and \ 95%
- Participant has undergone and failed at least 1 3-month or longer treatment regimen (ie, activity modification, weight loss, physical therapy, anti-inflammatory medications, or injection therapy) within a 2-year period...
- Study participant is able to speak, read, and understand English, in order to understand the nature of this study.
- Severe KOA (defined as KL grade \>3) on contralateral limb
- Has had prior total knee arthroplasty
- Has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol
- Has current or past history of malignancy (5y) excluding nonmelanoma skin cancer
- Has neurological, vascular, or cardiac condition that limit function, or, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- Has uncontrolled comorbidities including diabetes (hemoglobin A1c level \>7.0%), Hypertension (resting heart rate \>100 bpm, systolic blood pressure \>170 mmHg, or diastolic blood pressure \>90 mmHg), cardiovascular...
- Is known positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) or human immunodeficiency virus-1/2 antibody (HIV-1/2Ab). Patients with a negative RNA test for HCV are acceptable.
- Is taking a prohibited medication or has taken a prohibited medication (narcotic pain medication, local anti-inflammatory, other investigational drugs)
- Participant has had a change in medication to manage comorbid condition(s) (including diabestes, hypertension, asthma, and cardiovascular disease) within 1 month of the Screening visit.
- Participant received intra-articular cortisone or viscosupplementation product(eg, Synvisc®) injections within 3 months prior to the first dose of IMP.
- Has had administration of a live, attenuated vaccine within 28 days of starting study treatment or anticipation that such vaccine will be required during the study Prior/concurrent clinical study experience
- Has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- This criteria was deleted with protocol amendment 6
- This criteria was deleted with protocol amendment 6
- This criteria was deleted with protocol amendment 6
- Has current or past history (10y) of smoking
- Has a history of chronic alcohol or drug abuse within the previous 3 months
- Participant is currently using a systemic oral or intravenous steroid regimen (eg, for asthma or other chronic respiratory condition) or brief course of systemic pulse steroid administration (eg, for flare up of...
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Orange, California, United States
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, 50 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Orange, California, United States. 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.