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

NCT05034874 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: M200C-2201U01DA055481
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 9

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

Outcome Measures

Primary Outcomes (1)

• Percent of 20 Weeks Abstinent From Stimulants Following a 4-week Grace Period

  The difference in group means between the IXT-m200 and placebo groups for the percent of 20 weeks abstinent from stimulants following a 4-week grace period as measured by saliva screens in treatment-seeking individuals with Methamphetamine Use Disorder. All observations will be used, regardless of whether a participant discontinued treatment early. All missing values will be imputed assuming the participant is not abstinent.

  20 weeks

Secondary Outcomes (4)

• Change From Screening in Participant-rated Quality of Life as Measured by the Treatment Effectiveness Assessment at Week 13, 25, and 33.

  Weeks 13, 25, and 33

• Proportion of Responders in Early Remission at Week 25 as Measured by DSM-5 Criteria

  25 weeks

• Difference Between Groups in Clinical Global Impression of Change (CGIC) at Week 13, 25, and 33

  Weeks 13, 25, and 33

• Difference Between Groups in Patient Global Impression of Change (PGIC) at Week 13, 25, and 33

  Weeks 13, 25, and 33

Study Arms (2)

IXT-m200

EXPERIMENTAL

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

Drug: IXT-m200

Placebo

PLACEBO COMPARATOR

Saline

Other: Placebo

Interventions

IXT-m200 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.

IXT-m200

Placebo OTHER

Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Eligible participants will: 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• InterveXion Therapeutics, LLC: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (9)

Pillar Clinical Research

Bentonville, Arkansas, 72712, United States

Location

Woodlands International Research Group

Little Rock, Arkansas, 72211, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Pillar Clinical Research

Lincolnwood, Illinois, 60712, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

HD Research

Houston, Texas, 77008, United States

Location

Pillar Clinical Research

Richardson, Texas, 75080, United States

Location

Alpine Research

Clinton, Utah, 84015, United States

Location

Limitations and Caveats

Early termination due to missing data leading to small numbers of participants analyzed. Participants did not submit drug tests as required.

Results Point of Contact

• Title: Chief Operating Officer
• Organization: InterveXion Therapeutics, LLC

intervexion@gmail.com

501-554-2377

Study Officials

• Chief Medical Officer

  InterveXion Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 5, 2021
• Study Start: June 9, 2022
• Primary Completion: September 11, 2023
• Study Completion: November 7, 2023
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: These datasets will be available for distribution following submission to the FDA of the Clinical Study Report and publication. They will be available for 2 years after the initial publication.
• Access Criteria: These datasets and associated documentation will be made available on CD by the Sponsor to requestors under a data sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology and not distributing to third parties; and (3) a commitment to destroying or returning the data after analyses are completed. Requests should be sent to intervexion@gmail.com.

Locations

US (9)