Multiple Doses of AT-1501-A201 in Adults With ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

A Phase 2a Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Multiple Doses of AT-1501 in Adults With ALS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04322149
• Other study ID #: AT-1501-A201
• Status: Completed
• Phase: Phase 2
• Start date: October 16, 2020
• Est. completion date: March 24, 2022

Study information

• Verified date: June 2023
• Source: Eledon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40 ligand (CD40L). Approximately 54 adults with Amyotrophic Lateral Sclerosis (ALS) will be enrolled into the study in the United States and Canada at approximately 13 ALS treatment sites.

Participants will be enrolled into one of four ascending doses.

Description:

This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40L. Approximately 54 adults with ALS will be enrolled into the study in the United States and Canada at approximately 13 ALS treatment sites.

Four ascending doses of AT-1501 will be administered as an IV infusion to sequentially enrolling cohorts. Each participant will receive 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.

The study is estimated to take 19 weeks for participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 24, 2022
• Est. primary completion date: March 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. ALS diagnosed as possible, laboratory supported probable, probable, or definite as defined by revised El Escorial criteria

2. ALS Functional Rating Scale - Revised (ALSFRS-R) Aggregate score of 37 or greater

3. No more than 24 months from diagnosis

Exclusion Criteria:

1. Any other central or peripheral nervous system disease that may interfere with the evaluation of ALS or its progression

2. Presence of a tracheostomy, or use of permanent assistive ventilation (ventilatory support for 23 hours per day or more)

3. History of malignancy within the previous 5 years, except for localized non-melanoma skin cancers

4. Abnormal function of the immune system resulting from:

• Clinical conditions affecting the immune system (e.g. HIV infection, agammaglobulinemia),

• Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to 20 mg/day of prednisone for more than 14 consecutive days within 90 days prior to screening,

• Administration of anti-neoplastic and/or immunomodulating agents (e.g. Tumor necrosis factor alpha (TNF a) antagonists or anti-B cell antibodies) or radiotherapy within 1 year prior to screening.

5. Recipient of Stem Cell or Gene Therapy

6. Positive test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV.

7. History of deep venous thrombosis or pulmonary embolism

8. History of active substance abuse within the past 2 years

9. History of stroke, poorly controlled or significant cardiovascular disease, diabetes

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

Drug:
• AT-1501
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Locations

Country	Name	City	State
Canada	Montreal Neurological Institute and Hospital	Montreal
United States	Augusta University	Augusta	Georgia
United States	Johns Hopkins University Medical Center	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Texas Neurology, P.A.	Dallas	Texas
United States	Houston Methodist Neurological Institute	Houston	Texas
United States	University of Indiana	Indianapolis	Indiana
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	Hospital for Special Surgery (HSS)	New York	New York
United States	University of California Irvine	Orange	California
United States	Barrows Neurological Institute	Phoenix	Arizona
United States	Providence Brain & Spine Institute	Portland	Oregon
United States	California Pacific Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Anelixis Therapeutics, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Incidence of adverse events (AEs) reported as number of participants with at least one TEAE (Treatment Emergent Adverse Event) and at least one SAE (Serious Adverse Event).	Up to 18 Weeks
Primary	Safety and Tolerability	Incidence of adverse events (AEs) reported as number of TEAEs (Treatment Emergent Adverse Events) having occurred.	Up to 18 Weeks