Study of Multiple-Ascending-Dose Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations

NCT05890729 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: XTMAB-16-201 Part A
• Study Type: interventional
• Target: 32
• Locations: 6 countries
• Sites: 33

Brief Summary

Study of Multiple-Ascending-Dose Study of XTMAB-16 in Patients with Pulmonary Sarcoidosis with or Without Extrapulmonary Manifestations

Conditions

Pulmonary Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs), and Adverse Events of Special Interests (AESIs) throughout the study duration

  To evaluate the safety and tolerability of multiple ascending doses of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations

  Throughout Study Duration, 20 weeks

Secondary Outcomes (28)

• Pharmacokinetic (PK) profile including trough concentration (Ctrough)

  Baseline to Week 12

• Pharmacokinetic (PK) profile including maximum concentration (Cmax)

  Baseline to Week 12

• Pharmacokinetic (PK) profile including average concentration (Caverage)

  Baseline to Week 12

• Pharmacokinetic (PK) profile including area under the curve (AUC)

  Baseline to Week 12

• Dose normalized maximum serum concentration (Cmax/D)

  Baseline to Week 12

Study Arms (4)

Part A - XTMAB-16: 2 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo

EXPERIMENTAL

Drug: XTMAB-16 or Placebo

Part A - XTMAB-16: 4 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo

EXPERIMENTAL

Drug: XTMAB-16 or Placebo

Part A - XTMAB-16: 2 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo

EXPERIMENTAL

Drug: XTMAB-16 or Placebo

Part A - XTMAB-16: 4 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo

EXPERIMENTAL

Drug: XTMAB-16 or Placebo

Interventions

XTMAB-16 or Placebo DRUG

Infusion

Part A - XTMAB-16: 2 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo; Part A - XTMAB-16: 2 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo; Part A - XTMAB-16: 4 mg/kg every 2 weeks (Q2W) for 12 weeks or Placebo; Part A - XTMAB-16: 4 mg/kg every 4 weeks (Q4W) for 12 weeks or Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant between 18 to 80 years (inclusive) of age.
• 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 ≥ 1.
• 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.
• 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.
• In the opinion of the Investigator, the participant is capable of understanding and complying with protocol requirements

You may not qualify if:

• Pregnant or breastfeeding women or women who are planning to become pregnant during the study.
• 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.
• A historical HRCT performed within 6 months of screening may be submitted for diagnostic confirmation by central review. If a subject's last HRCT was from \> 6 months of screening, an HRCT should be performed during screening for diagnostic confirmation by central review.
• Any prior TNFα inhibitor therapy.
• Clinically significant extra-pulmonary sarcoidosis requiring systemic therapy as determined by the investigator.
• Baseline percent predicted forced vital capacity (FVC) of \< 50%.
• Prior treatment with rituximab or repository corticotropin injection within the previous 12 months.
• Clinically significant Central Nervous System (CNS) sarcoidosis requiring therapy, except history of isolated seventh cranial nerve palsy or evidence of demyelinating neurologic disease.
• Advanced congestive heart failure (New York Heart Association \[NYHA\] 3 or 4).
• Current disease presentation consistent with Lofgren's syndrome (i.e., presence of the triad of erythema nodosum, bilateral hilar lymphadenopathy on chest X-ray, and joint pain).
• 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.
• Known hypersensitivity to any component of the formulation of XTMAB-16.
• Live or messenger ribonucleic acid (mRNA) vaccination within 2 weeks before Day 1 or inoculation with a live or mRNA vaccine is planned during study participation.
• Evidence of active or latent TB by interferon-gamma release assay (IGRA) or invasive fungal infections at Screening.
• Known positive history of malignancy other than non-melanomatous skin cancer in the last 2 years, including in-situ carcinoma of the uterine cervix completely cured by radical surgery.

Sponsors & Collaborators

• Xentria, Inc.: lead

Study Sites (33)

Xentria Investigative Site

Birmingham, Alabama, 35233, United States

Location

Xentria Investigative Site

Denver, Colorado, 80206, United States

Location

Xentria Investigative Site

Jacksonville, Florida, 32209, United States

Location

Xentria Investigative Site

Chicago, Illinois, 60611, United States

Location

Xentria Investigative Site

Chicago, Illinois, 60612, United States

Location

Xentria Investigative Site

Iowa City, Iowa, 52242, United States

Location

Xentria Investigative Site

Baltimore, Maryland, 21287, United States

Location

Xentria Investigative Site

Detroit, Michigan, 48202, United States

Location

Xentria Investigative Site

Minneapolis, Minnesota, 55455, United States

Location

Xentria Investigative Site

Albany, New York, 12208, United States

Location

Xentria Investigative Site

New York, New York, 10029, United States

Location

Xentria Investigative Site

Greenville, North Carolina, 27858, United States

Location

Xentria Investigative Site

Cincinnati, Ohio, 45267, United States

Location

Xentria Investigative Site

Philadelphia, Pennsylvania, 19140, United States

Location

Xentria Investigative Site

Charleston, South Carolina, 29425, United States

Location

Xentria Investigative Site

Charlottesville, Virginia, 22903, United States

Location

Xentria Investigative Site

Prague, 140 59, Czechia

Location

Xentria Investigative Site

Aalborg, 9000, Denmark

Location

Xentria Investigative Site

Aarhus, 8200, Denmark

Location

Xentria Investigative Site

Odense, 5000, Denmark

Location

Xentria Investigative Site

Roskilde, 4000, Denmark

Location

Xentria Investigative Site

Vejle, 7100, Denmark

Location

Xentria Investigative Site

Bielsk Podlaski, 15-044, Poland

Location

Xentria Investigative Site

Lodz, 90-153, Poland

Location

Xentria Investigative Site

Barcelona, 08035, Spain

Location

Xentria Investigative Site

Barcelona, 08036, Spain

Location

Xentria Investigative Site

Seville, 41013, Spain

Location

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, England, CV22DX, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, England, NW12PG, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, England, SE59RS, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, England, NR47UY, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, England, OX37LE, United Kingdom

Location

NHS Tayside

Perth, Scotland, PH11NX, United Kingdom

Location

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 6, 2023
• Study Start: November 10, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

CZ (1); PL (2); GB (6); US (16); DK (5); ES (3)