A Seamless, Adaptive Multiple-Ascending-Dose and Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations

NCT07680166 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: XTMAB-16-201 Part B
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study of XTMAB-16 in patients with pulmonary sarcoidosis

Conditions

Pulmonary Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in forced vital capacity (FVC) milliliter (mL)

  To establish efficacy of XTMAB-16 as measured by forced vital capacity (FVC) milliliter (mL) in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations

  Baseline to Week 24

Secondary Outcomes (3)

• Quality of Life King's Sarcoidosis Questionnaire-Lung (KSQ-L) mean change

  Baseline to Week 24 and 52

• Proportion of participants who maintain disease control (as defined by no greater than 1 worsening [exacerbation] event)

  Baseline to Week 52

• Absolute change from baseline in forced vital capacity (FVC) milliliter (mL)

  Baseline to Week 52

Study Arms (2)

XTMAB-16 4 mg/kg Q2W for 3 doses, then Q4W IV up to 52 weeks

EXPERIMENTAL

Drug: XTMAB-16

Placebo 4 mg/kg Q2W for 3 doses, then Q4W IV up to 52 weeks

PLACEBO COMPARATOR

Drug: Placebo

Interventions

XTMAB-16 DRUG

Infusion

XTMAB-16 4 mg/kg Q2W for 3 doses, then Q4W IV up to 52 weeks

Placebo DRUG

Infusion

Placebo 4 mg/kg Q2W for 3 doses, then Q4W IV up to 52 weeks

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 and 80 years (inclusive) of age.
• Weighs between 45 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 World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) criteria including a compatible clinical and radiologic presentation with other causes of granulomatous disease ruled out (cutaneous and ocular involvement permitted).
• mMRC Dyspnea Scale of ≥1.
• Baseline pre-BD ppFVC of ≥ 50% during screening window, and confirmed at the Baseline visit prior to enrollment and dosing.
• Receiving corticosteroid treatment 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.
• Radiographic evidence of disease in the lung parenchyma (at least Scadding stage II disease) without the presence of significant fibrosis.
• Note: Significant fibrotic disease is defined as fibrosis \> 20% as determined by central read.
• 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 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 participant's last HRCT was from \>6 months of screening, an HRCT should be performed during screening for diagnostic confirmation by central review. Note: Significant fibrotic disease is defined as \>20% fibrosis on HRCT.
• Clinically significant extra-pulmonary sarcoidosis requiring systemic therapy as determined by the Investigator.
• Any therapy with an anti-TNFα monoclonal antibody (e.g., infliximab, adalimumab, golimumab and their biosimilars) within 6 months.
• Baseline pre-BD ppFVC of \>85%.
• Prior treatment with rituximab or repository corticotropin injection within the previous 12 months.
• Clinically significant 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 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.
• Evidence of active or latent tuberculosis (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.
• Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, coronavirus disease (COVID-19), TB, or a known history of human immunodeficiency virus (HIV) infection at Screening.
• Women of childbearing potential who are sexually active with a non-sterilized male partner and are not willing to adhere to highly effective birth control measures from the time of signing the informed consent, throughout the duration of the study, and for 90 days after 5 half-lives have elapsed since the last dose of study drug. See Appendix 4 for details on contraception requirements during the study.

Sponsors & Collaborators

• Xentria, Inc.: lead

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06