ClinicaliQ Trial Snapshot
- A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis — Recruiting • Phase I • Respiratory / COPD / Asthma • NCT05890729.
- What is being tested: XTMAB-16, an investigational monoclonal antibody, is being evaluated in a phase 1b/2 study as a potential new treatment for pulmonary sarcoidosis, with assessment of safety, tolerability, and efficacy across dose escalation and expansion phases.
- Patient eligibility overview: The trial enrolls patients with confirmed pulmonary sarcoidosis, typically those with active disease who may have inadequate response to, intolerance of, or contraindications to conventional therapies such as corticosteroids.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
A phase 1b/2 study of XTMAB-16 in patients with pulmonary sarcoidosis
Eligibility Snapshot
- :
- Participant between 18 to 80 years (inclusive) of age. 2. Weighs between 45 kg and 160 kg (99 to 353 lbs) at Screening. 3. Diagnosis of pulmonary sarcoidosis (at least 6 months before Screening) using the 2020 American Thoracic Society (ATS) Clinical Practice Guideline (Crouser et al, 2020), the European Respiratory Society (ERS) or the WASOG criteria including a compatible clinical and radiologic presentation with other causes of granulomatous disease ruled out (cutaneous and ocular involvement permitted). 4. Modified Medical Research Conference (mMRC) Dyspnea Scale of ≥ 1. 5. Receiving treatment of 7.5 to 25 mg/day of oral prednisone, or equivalent, during the screening period and, at the determination of the investigator, is capable of undergoing the protocol specific corticosteroid taper regimen. 6. Receiving treatment with methotrexate, azathioprine, mycophenolate, leflunomide, chloroquine, or hydroxychloroquine for at least 3 months before Screening that has been at a stable dose for 4 weeks before Screening. All efforts should be made to maintain stable background therapy at the Screening dose through the intervention period at the Investigator's discretion. 7. PART A only: Willing to refrain from consumption of grapefruit or grapefruit juice [pomelos, exotic citrus fruits, or grapefruit hybrids] from screening…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.