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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

Must not have

Known positive history of malignancy other than non-melanomatous skin cancer in the last 2 years, including cervical carcinoma in-situ

Donation or loss of 450 mL or more of his or her blood volume (including plasmapheresis) or transfusion of any blood product within 90 days prior to dosing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 to week 24 (part b)

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer other than non-melanoma skin cancer or cervical carcinoma in-situ in the last 2 years.

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I haven't donated or lost significant blood, or received a transfusion in the last 3 months.

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My condition matches Lofgren's syndrome symptoms.

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My heart condition severely limits my daily activities.

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I haven't been hospitalized in the last 3 months and don't expect to be during the study.

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I do not have active or latent TB or fungal infections.

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I am currently taking steroids for a condition other than sarcoidosis.

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I have high blood pressure that isn't controlled by medication.

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I have not received a live or mRNA vaccine in the last 2 weeks and do not plan to during the study.

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My lung function is less than half of what is expected for someone my age and size.

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I have tested positive for hepatitis B, hepatitis C, COVID-19, TB, or HIV.

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I need treatment for sarcoidosis outside my lungs as decided by my doctor.

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I am currently being treated for an autoimmune disease.

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I am being treated for severe high blood pressure in my lungs.

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I have previously received TNFα inhibitor therapy.

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I have emphysema.

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I have had symptoms like fever or cough, or a confirmed COVID-19 test in the last 4 weeks.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 to week 24 (part b) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Adverse Events, including Serious Adverse Events, Dose Limiting Toxicities, and Adverse Events of Special Interest throughout the study duration

Secondary study objectives

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

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