NG004 in Spinal Cord Injury Patients (SPROUT)

A First-in-human (FIH) Clinical Trial to Investigate the Human Monoclonal Antibody NG004, Administrated Intrathecally in Acute Spinal Cord Injury (SCI) Patients

This is the FIH, multicenter, open-label, sequential, multiple ascending dose trial of NG004 in patients with acute incomplete cervical SCI. The trial will evaluate the safety, tolerability, and PK of 4 dose regimens of NG004, and will evaluate the maximum tolerated dose of NG004.

Study Overview

• Status: Recruiting
• Conditions: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Acute Spinal Cord Injury (SCI); Spinal Cord Injuries (SCI)
• Intervention / Treatment: Drug: NG004

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Director of Clinical Research; Phone Number: +41433005263; Email: clinical@novagotx.com

Study Locations

• Germany
  • Bayreuth, Germany
    • Recruiting
    • Klinik für Querschnittgelähmte, Klinikum Bayreuth
  • Halle, Germany
    • Not yet recruiting
    • Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost
  • Heidelberg, Germany
    • Recruiting
    • Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
  • Murnau Am Staffelsee, Germany
    • Recruiting
    • Zentrum für Rückenmarksverletzte, Unfallklinik Murnau
• Switzerland
  • Nottwil, Switzerland
    • Recruiting
    • Swiss Paraplegic Centre
  • Zurich, Switzerland
    • Recruiting
    • Universitätsklinik Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) C-D at Screening
• 4-28 days post-injury
• No required mechanical ventilation or patients that not completely depend on mechanical ventilation
• Hemodynamically and clinical stable patient according to the acute SCI condition at baseline

Exclusion Criteria:

• Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds
• Multiple levels of clinically relevant spinal cord lesions
• Major brachial or lumbar plexus damage/trauma
• Significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function
• Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy
• History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome History of recent (6 months) meningitis or meningoencephalitis
• History of refractory epilepsy
• History of or current autoimmune disease
• Patients with uncontrolled bleeding diathesis and/or who require concomitant therapeutic anticoagulation and not related to SCI
• Presence of any unstable medical or psychiatric condition
• Drug dependence any time during the 6 month's preceding trial entry
• Pregnant or nursing women
• History of a life-threatening allergic or immune mediated reaction
• Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections
• Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations
• Patients who are unconscious

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NG004	Drug: NG004; repeated intrathecal injections of NG004

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions	From treatment start up to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Plasma Concentration [Cmax] in serum	After first and last intrathecal injection, measured at pre-dose and 1, 3, 6, 24, 48 hours post-dose.
Half-life in serum [T1/2]	After last intrathecal injection up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on motor function as Change from Baseline in ISNCSCI upper extremities motor score (UEMS), according to the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol	The ISNCSCI bilateral Upper Extremity Motor Score (UEMS) is determined by examining the muscle function within each of the 5 myotomes encompassing arm and hand function on each side of the body. A score ranging from 0 to 5 can be given to each myotome tested resulting in a maximum score of 50. Higher values indicate better recovery.	Baseline up to 6 months
Effect on daily life functioning according to change in Version III of the Spinal Cord Independence Measure (SCIM-III)	The SCIM III questionnaire self-care score assesses activities of daily living including feeding, bathing, dressing, and grooming. The self-care score ranges 0-20. The higher scores correspond to better ability to carry out the self-care activities.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: NovaGo Therapeutics AG
• Investigators: Study Director: Director of Clinical Research, NovaGo Therapeutics AG

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Regeneration; SPROUT; Nogo-A; Acute spinal cord injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Cord Injuries; Nervous System Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Trauma, Nervous System
• Other Study ID Numbers: NG004-SCI-001; 2024-514303-34-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No