Clinical trial NCT06817577: NG004 in Spinal Cord Injury Patients
Official title: A First-in-human (FIH) Clinical Trial to Investigate the Human Monoclonal Antibody NG004, Administrated Intrathecally in Acute Spinal Cord Injury (SCI) Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Acute Spinal Cord Injury (SCI)
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Spinal Cord Injuries (SCI)
Wounds and Injuries
Keywords: Acute spinal cord injury
Nogo-A
SPROUT
Regeneration
Lead sponsor: NovaGo Therapeutics AG
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions
timeFrame: From treatment start up to 6 months
Secondary outcomes:
measure: Maximum Plasma Concentration [Cmax] in serum
timeFrame: After first and last intrathecal injection, measured at pre-dose and 1, 3, 6, 24, 48 hours post-dose.
measure: Half-life in serum [T1/2]
timeFrame: After last intrathecal injection up to 6 months
Other outcomes:
measure: 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
timeFrame: Baseline up to 6 months
measure: Effect on daily life functioning according to change in Version III of the Spinal Cord Independence Measure (SCIM-III)
timeFrame: Baseline to 6 months
Locations:
city: Bayreuth
country: Germany
facility: Klinik für Querschnittgelähmte, Klinikum Bayreuth
city: Halle
country: Germany
facility: Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost
city: Heidelberg
country: Germany
facility: Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
city: Murnau Am Staffelsee
country: Germany
facility: Zentrum für Rückenmarksverletzte, Unfallklinik Murnau
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
city: Zurich
country: Switzerland
facility: Universitätsklinik Balgrist
Study officials:
affiliation: NovaGo Therapeutics AG
name: Director of Clinical Research
role: STUDY_DIRECTOR
References: