Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200

NCT ID: NCT05034874

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-09
• Study Completion Date: 2023-11-07

Brief Summary

This Phase 2 study will evaluate the safety and efficacy of monthly intravenous doses of IXT-m200 in treatment-seeking individuals with methamphetamine (METH) use disorder. The hypothesis are that following an initial relapse, IXT-m200 will reduce the occurrence of stimulant-positive saliva samples compared to placebo and improve the signs and symptoms of METH Use Disorder (MUD).

Conditions

Methamphetamine-dependence; Methamphetamine Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IXT-m200

Anti-methamphetamine monoclonal antibody, dose levels of 1.5 and 3 g

Group Type: EXPERIMENTAL

IXT-m200

Intervention Type: DRUG

IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.

Placebo

Saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Saline

Interventions

IXT-m200

IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.

Intervention Type: DRUG

Placebo

Saline

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Be at least 18 years of age at the time of study consent;

2. Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Substance Use Disorder associated with methamphetamine;

3. Be treatment-seeking methamphetamine users with at least 1 methamphetamine or amphetamine positive specimen during the screening period;

4. Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent;

5. Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study;

6. Agree to use protocol-specified method(s) of birth control throughout study participation;

7. Agree to adhere to Lifestyle Considerations throughout study duration;

8. Have access to a smartphone or other device capable of supporting the study app;

9. Successfully complete app-based training program as evidenced by completion of at least 75% of daily drug use surveys and assigned saliva drug screens (two of which must be valid) in ≤30 days from the screening visit during the screening period.

Eligible participants will NOT:

1. Have current dependence, defined by DSM-5 criteria, on any psychoactive substance (i.e., opioids or benzodiazepines), other than methamphetamine or nicotine (any severity). Mild severity dependence on alcohol or marijuana is allowed;

2. Be currently taking certain other drugs and medications, including: "designer drugs" (e.g., 3,4-methylenedioxyMETH (MDMA, Ecstasy, Adam, XTC) and its N-dimethyl metabolite methylenedioxyamphetamine (MDA), anti-orexigenic drugs (including over-the-counter medications for weight loss), or be chronic users of phenethylamine compounds (e.g., phenylpropanolamine, ephedrine, pseudoephedrine, amphetamine, phentermine, phenmetrazine, methylphenidate, diethylpropion, and propylhexedrine);

3. Have a known contraindication or sensitivity to IXT-m200 based on known allergies to other monoclonal antibodies, any inactive ingredient of IXT-m200, or any other products required for the study procedures;

4. Have a history of severe allergy (rash, hives, breathing difficulty, etc) to any medications;

5. Have a history of allergic or environmental bronchial asthma within the past 3 years;

6. Have a current diagnosis of anorexia nervosa or bulimia disorder;

7. Have a history of unstable cardiovascular disease that is not adequately controlled at the time of eligibility determination;

8. Be mandated by the court to obtain treatment for methamphetamine-dependence where such mandate required the results of methamphetamine testing to be reported to the court;

9. Have positive saliva drug screens for psychoactive substances other than amphetamines at the screening visit;

10. Be expected to fail to complete the study protocol due to probable incarceration or relocation from the clinic area, or any clinically significant mental or physical illness within a 1-year prior, that would impact compliance with trial requirements;

11. Have clinically significant laboratory values (outside of normal limits). The following specified ranges are allowable:

1. Liver function tests (total, direct, and indirect bilirubin, aspartate transaminase, alanine aminotransferase, gamma-glutamyl transferase, lactate dehydrogenase, and alkaline phosphatase) <3 times the upper limit of normal, and

2. Kidney function tests (creatinine and BUN) <2 times the upper limit of normal;

12. Be considered to be at imminent risk of suicide or have a past-year history of a serious suicide attempt (defined as an attempt that results in or requires medical treatment) based on response to queries within eligibility screening about suicidal ideation and attempts;

13. Have an uncontrolled systemic disease or a medical condition that may increase the risk associated with study participation or administration of study treatment or that may interfere with the interpretation of study results;

14. Be currently participating or has participated within the last 30 days prior to the start of this study in a drug, device, or other interventional research study;

15. Be pregnant or lactating;

16. In the Investigator's or Sponsor's (or designee) opinion, be inappropriate for the study, including those believed to be attempting to enter the study primarily for financial gain.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

InterveXion Therapeutics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

InterveXion Therapeutics

Locations

Pillar Clinical Research

Bentonville, Arkansas, United States

Woodlands International Research Group

Little Rock, Arkansas, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Pillar Clinical Research

Lincolnwood, Illinois, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

InSite Clinical Research

DeSoto, Texas, United States

HD Research

Houston, Texas, United States

Pillar Clinical Research

Richardson, Texas, United States

Alpine Research

Clinton, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U01DA055481

Identifier Type: NIH

Identifier Source: secondary_id

View Link

M200C-2201

Identifier Type: -

Identifier Source: org_study_id