Phase 2 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 to 80 years (inclusive)
• People who weigh between 45 kg and 160 kg (approximately 99 to 353 lbs) at the screening visit
• People who have been diagnosed with pulmonary sarcoidosis (a lung condition caused by clusters of inflammatory cells) at least 6 months before screening, confirmed using recognised medical guidelines, with other possible causes ruled out — skin or eye involvement is permitted
• People who experience at least some shortness of breath in daily life, as measured by a standard breathlessness scale (mMRC score of 1 or higher)
• People currently taking a daily oral steroid (such as prednisone) at a dose of 7.5 to 25 mg per day, or an equivalent steroid, during the screening period, and whom the trial doctor considers able to follow a gradual steroid dose-reduction plan as set out in the trial
• People who have been taking one of the following medicines for at least 3 months before screening, at a stable dose for at least 4 weeks: methotrexate, azathioprine, mycophenolate, leflunomide, chloroquine, or hydroxychloroquine
• People who test negative for COVID-19 (by PCR or rapid antigen test) at screening
• People who are able to give written informed consent and, in the trial doctor's opinion, are able to understand and follow the trial requirements
• Part A of the trial only: People who are willing to avoid grapefruit, grapefruit juice, pomelos, exotic citrus fruits, or grapefruit hybrids from the screening visit until after the final dose

Who may not be able to join:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• Part A only (EU sites only): People older than 65 years of age
• Part A only: People with significant scarring (fibrosis) in the lungs and/or inflammation found only in the central chest region (hilar area) on a detailed CT scan, as confirmed by a central reviewer — people who have inflammation in that area alongside inflammation elsewhere in the lungs may still be considered (confirm with trial site)
• Part A only: People who have previously received a type of medicine called a TNF-alpha inhibitor
• People whose sarcoidosis has significantly affected organs outside the lungs in a way that requires ongoing systemic (whole-body) treatment, as determined by the trial doctor
• Part B only: People who have been treated with certain anti-TNF-alpha medicines (such as infliximab, adalimumab, golimumab, or their biosimilars) within the past 6 months
• People whose lung function test (forced vital capacity, or FVC) shows the lungs are working at less than 50% of what would be expected for their age and size
• People who have received rituximab or a medicine called repository corticotropin injection within the past 12 months
• People with sarcoidosis significantly affecting the brain or nervous system that requires treatment — with the exception of a past history of a specific type of facial nerve palsy (seventh cranial nerve palsy) or evidence of a demyelinating nerve condition
• People with advanced heart failure (classified as Stage 3 or 4 by standard medical criteria)
• People whose current symptoms match a specific pattern called Löfgren's syndrome — a combination of a particular skin rash (erythema nodosum), swollen lymph nodes in the chest visible on X-ray, and joint pain
• People with significant high blood pressure in the lungs (pulmonary hypertension) that requires treatment with specific medicines such as prostacyclins, PDE5 inhibitors, or endothelin receptor antagonists
• People with a known allergy or sensitivity to any ingredient in the study drug (XTMAB-16)
• People who have received a live or mRNA vaccine within 2 weeks before the first dose, or who plan to receive one during the study
• People who show signs of active or latent (dormant) tuberculosis (TB), or active invasive fungal infection, at screening
• People with a history of cancer (other than certain non-melanoma skin cancers or a fully surgically treated cervical carcinoma-in-situ) within the past 2 years
• People who test positive at screening for hepatitis B, hepatitis C, COVID-19, or TB, or who have a known history of HIV infection
• Women who could become pregnant, are sexually active with a male partner who has not had a vasectomy, and are not willing to use highly effective contraception from consent through the study and for 90 days after a period equivalent to five times the drug's half-life following the last dose
• Male participants who have not had a vasectomy, are sexually active with a female partner who could become pregnant, and are not willing to use highly effective contraception from consent through the study and for 90 days after a period equivalent to five times the drug's half-life following the last dose
• People with significant liver or kidney disease, or poorly controlled diabetes, as determined by the trial doctor
• People who have had a severe reaction to any type of biologic medicine or human blood product (such as albumin or immunoglobulin)
• People who also have emphysema (a separate type of lung condition)
• People with high calcium levels in the blood caused by a condition other than sarcoidosis (such as untreated overactive parathyroid glands), as determined by the trial doctor
• People with certain abnormal heart rhythm or electrical activity findings on an ECG — including specific irregular heartbeat patterns, conduction problems, or abnormal intervals — as outlined in the trial criteria (confirm with trial site)
• People who have donated or lost 450 mL or more of blood (including through plasma donation) or received a blood transfusion within the 90 days before the first dose
• People with uncontrolled high blood pressure (blood pressure of 160/100 mmHg or higher despite taking blood pressure medication) within 3 months before being assigned to a treatment group
• People who have had symptoms consistent with COVID-19 (such as fever, dry cough, breathlessness, sore throat, fatigue, or new loss of smell or taste), or a confirmed COVID-19 infection, within 4 weeks before screening
• People whom the trial doctor believes would not be able to tolerate a gradual reduction in steroid dose
• People currently taking systemic (whole-body) steroids for a condition other than sarcoidosis
• People with a known autoimmune disease that requires ongoing treatment
• People who have taken part in another clinical trial of an investigational medicine within the past 3 months (for small-molecule drugs), 6 months (for biologic medicines), or 5 half-lives of that drug — whichever is the longer period
• People who required hospitalisation within the 3 months before the first dose, or who are likely to need hospitalisation during the study
• People with clinically significant abnormalities found during screening (physical examination, medical history, vital signs, ECG, or lab tests) that are not explained by sarcoidosis and that, in the trial doctor's opinion, would make participation unsafe

Important: Always verify eligibility with the trial site directly before applying.