A seamless, phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations
- Conditions
- Pulmonary sarcoidosis with or without extrapulmonary manifestationsMedDRA version: 20.1Level: PTClassification code: 10039486Term: Sarcoidosis Class: 100000004870Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2022-502877-41-00
- Lead Sponsor
- Xentria Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 94
Participant between 18 to 80 years (inclusive) of age., In the opinion of the Investigator, the participant is capable of understanding and complying with protocol requirements., Weighs between 45 kg and 160 kg (99 to 353 lbs) at Screening., 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)., Modified Medical Research Conference (mMRC) Dyspnea Scale of = l., 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., 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., PART A only: Willing to refrain from consumption of grapefruit or grapefruit juice [pomelos, exotic citrus fruits or grapefruit hybrids] from screening visit until after the final dose., Polymerase chain reaction (PCR) test or rapid antigen test negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening., Able to provide written informed consent.
PART A ONLY: Known potentially significant fibrotic disease and/or active inflammation contained solely in the hilar region as shown by high-resolution computed tomography (HRCT), confirmed by a central reader. Participants with current active inflammation in the hilar region with concurrent inflammation outside the hilar region may be included. For participants with disease onset of <2 years, a historical computed tomography (CT) within 6 months prior to screening confirmed by a central read is acceptable. For participants with disease onset of >2 years and without a CT within 6 months prior to screening, a CT will be performed at Screening. Note: For all participants, regardless of their time of disease onset, if a historical HRCT is to be submitted for diagnosis confirmation, that HRCT must have been performed within 6 months of screening. If their last HRCT was from > 6 months prior to screening, then they will need to have an HRCT performed during screening for diagnosis confirmation. Note: Significant fibrotic disease is defined as > 20% fibrosis on HRCT, Clinically significant hepatic or renal disease, including uncontrolled diabetes at the discretion of the investigator., Any severe prior reaction to any type of biologics or human blood product such as albumin, IgG, etc., PART A ONLY: Any prior TNFa inhibitor therapy., Concurrent emphysema., Known hypercalcemia due to non-sarcoidosis conditions such as untreated hyperparathyroidism, at the discretion of the investigator, Abnormal ECG: ventricular arrhythmias (non-sustained ventricular tachycardia (VT), multifocal or frequent premature ventricular contractions, bundle branch block, axis deviation, or abnormal Q waves). In the case of a QTcF (corrected QT interval by Fredericia) interval >450 ms (men) or >480 ms (women; participants with bundle branch block) or PR interval outside the range of 120 to 220 ms, the assessment may be repeated once for eligibility determination at Screening or Baseline., 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., Known uncontrolled hypertension. Note: Uncontrolled hypertension is noted as blood pressure = 160/100 mmHg despite antihypertensive therapy within 3 months of randomization., Clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, sore throat, fatigue, new smell or taste disorder or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening., In the opinion of the investigator, inability to tolerate corticosteroid taper., Clinically significant pulmonary hypertension requiring treatment. Note: Clinically significant pulmonary hypertension requiring treatment would be defined as treatment with, i.e., prostacyclins, phosphodiesterase 5 inhibitors, and endothelin receptor antagonists., Concurrent systemic steroid use for non-sarcoidosis conditions., Concurrent known auto-immune disease requiring treatment., Participation in another clinical trial of an investigational agent within 3 months (small molecule) / 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer., Clinically significant extra-pulmonary sarcoidosis requiring systemic therapy as determined by the investigator, Any condition that required hospitalization within the 3 months prior to Day 1 or is likely to require so during the study., Clinically significant abnormalities in the S
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method