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Monoclonal Antibodies
XTMAB-16 for Sarcoidosis
Phase 1 & 2
Recruiting
Research Sponsored by Xentria, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Modified Medical Research Conference (mMRC) Dyspnea Scale of ≥1
Participant between 18 and 80 years (inclusive) of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 to week 24 (part b)
Awards & highlights
Study Summary
This trial will test an experimental drug to treat a lung disease called sarcoidosis.
Who is the study for?
Adults aged 18-80 with pulmonary sarcoidosis, able to follow the study plan, weighing 45-160 kg, and on stable doses of certain medications can join. They must not have been hospitalized recently or be likely to need hospitalization during the trial. Participants should not have other significant health issues like uncontrolled diabetes or hypertension, recent malignancies (except some skin cancers), severe reactions to biologics, active infections including COVID-19 and TB, or require certain treatments for sarcoidosis.Check my eligibility
What is being tested?
The trial is testing XTMAB-16 against a placebo in patients with pulmonary sarcoidosis. It's an early-stage study (phase 1b/2) designed to evaluate how safe XTMAB-16 is and how well it works compared to a non-active treatment.See study design
What are the potential side effects?
Since this is an early-phase trial for XTMAB-16, specific side effects are being studied but may include typical reactions related to immune system drugs such as infusion-related symptoms, potential organ inflammation, fatigue, allergic responses or increased susceptibility to infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience shortness of breath when I exert myself.
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I am between 18 and 80 years old.
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My weight is between 99 and 353 lbs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12 to week 24 (part b)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 to week 24 (part b)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Adverse Events, including Serious Adverse Events, Dose Limiting Toxicities, and Adverse Events of Special Interest throughout the study duration
Secondary outcome measures
Proportion of participants who achieve at least 50% reduction in dose of corticosteroid by Week 12
Proportion of participants who achieve the targeted tapered dose of corticosteroid
Proportion of patients able to maintain steroid reduction through Week 24
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Part B - XTMAB-16 (dose established in Part A) for 24 weeks or PlaceboExperimental Treatment1 Intervention
Group II: Part A - XTMAB-16: 4 mg/kg every 4 weeks (Q4W) for 12 weeks or PlaceboExperimental Treatment1 Intervention
Group III: Part A - XTMAB-16: 4 mg/kg every 2 weeks (Q2W) for 12 weeks or PlaceboExperimental Treatment1 Intervention
Group IV: Part A - XTMAB-16: 2 mg/kg every 4 weeks (Q4W) for 12 weeks or PlaceboExperimental Treatment1 Intervention
Group V: Part A - XTMAB-16: 2 mg/kg every 2 weeks (Q2W) for 12 weeks or PlaceboExperimental Treatment1 Intervention
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Who is running the clinical trial?
Xentria, Inc.Lead Sponsor
3 Previous Clinical Trials
344 Total Patients Enrolled
1 Trials studying Sarcoidosis
94 Patients Enrolled for Sarcoidosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer other than non-melanoma skin cancer or cervical carcinoma in-situ in the last 2 years.I am taking a low to moderate dose of prednisone or similar medication, and can follow a specific plan to reduce it.I haven't donated or lost significant blood, or received a transfusion in the last 3 months.I have not taken rituximab or repository corticotropin in the last year.My condition matches Lofgren's syndrome symptoms.You tested negative for COVID-19 using a PCR or rapid antigen test before the screening.I experience shortness of breath when I exert myself.I am between 18 and 80 years old.I have a confirmed lung condition with inflammation or scarring in a specific lung area.You are allergic to any part of the XTMAB-16 medication.I've been on stable doses of specific medications for my condition for over 3 months.My heart condition severely limits my daily activities.My weight is between 99 and 353 lbs.My heart's electrical activity is not normal, as shown by an ECG.I need treatment for a serious brain condition, but not for isolated facial nerve issues or multiple sclerosis-like diseases.I have been diagnosed with pulmonary sarcoidosis for at least 6 months.I haven't been hospitalized in the last 3 months and don't expect to be during the study.I do not have active or latent TB or fungal infections.I am a man who can father children and will not use birth control during and after the study.I have high calcium levels not caused by sarcoidosis, as confirmed by a doctor.I am currently taking steroids for a condition other than sarcoidosis.I do not have serious liver, kidney disease, or uncontrolled diabetes.I haven't taken anti-TNFα drugs like infliximab in the last 6 months.I have high blood pressure that isn't controlled by medication.I have not received a live or mRNA vaccine in the last 2 weeks and do not plan to during the study.You have had a serious reaction to biologic drugs or human blood products in the past.My lung function is less than half of what is expected for someone my age and size.I have tested positive for hepatitis B, hepatitis C, COVID-19, TB, or HIV.I need treatment for sarcoidosis outside my lungs as decided by my doctor.I am currently being treated for an autoimmune disease.I have not been in a drug study within the past 3 to 6 months, depending on the type of drug.I understand and can follow the study's requirements.I am being treated for severe high blood pressure in my lungs.I have previously received TNFα inhibitor therapy.I have emphysema.I have had symptoms like fever or cough, or a confirmed COVID-19 test in the last 4 weeks.I am willing to use birth control during and after the study if I can become pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Part A - XTMAB-16: 4 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo
- Group 2: Part A - XTMAB-16: 2 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo
- Group 3: Part B - XTMAB-16 (dose established in Part A) for 24 weeks or Placebo
- Group 4: Part A - XTMAB-16: 2 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo
- Group 5: Part A - XTMAB-16: 4 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies within this research project for participants?
"If we consult clinicaltrials.gov, it appears that this research is presently looking for participants. The protocol was first promulgated on July 1st 2023 and revised most recently on the 24th of July in the same year."
Answered by AI
How many individuals can take part in this trial experimentally?
"Affirmative. According to clinicaltrials.gov, this research is presently admitting individuals for participation; the original posting date was July 1st 2023 and the most recent edit happened on July 24th 2023. 94 participants are necessary between a single medical centre."
Answered by AI
Is this clinical investigation open to those aged 35 or over?
"The age range for enrollment in this investigation is between 18 and 80 years old, as described by the inclusion criteria."
Answered by AI
Am I eligible to take part in this investigation?
"This clinical trial is recruiting 94 participants aged 18 to 80 who have been diagnosed with pulmonary sarcoidosis for at least 6 months and meet the criteria detailed above. They should also be taking 7.5-25 mg/day of oral prednisone (or equivalent) and abstain from consuming grapefruit products during the screening period until after their final dose, in addition to testing negative for SARS-CoV-2 upon entry into the study. Furthermore, they must provide written informed consent that indicates they are able to comprehend and adhere to protocol instructions."
Answered by AI
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