ABBV-CLS-7262 for ALS

Recruiting at 15 trial locations

Overseen By Calico Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must be taking: Standard ALS medications

Disqualifiers: Dementia, Malignancy, Pregnancy, Drug abuse, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called ABBV-CLS-7262 to see if it can help people with Amyotrophic Lateral Sclerosis (ALS). The study will have two parts: an initial short phase where some people get the drug, followed by a longer phase where everyone gets the drug. The goal is to see if the drug can protect nerve cells and slow down the disease.

Will I have to stop taking my current medications?

If you are taking standard ALS medications, you must be on a stable dose for more than 30 days before starting the trial. This means you can continue your current medications if they are stable.

What data supports the effectiveness of the drug ABBV-CLS-7262 for ALS?

The research mentions that AMX0035, a drug recently approved for ALS, has shown potent therapeutic effects in clinical trials, suggesting that novel experimental drugs can be effective in treating ALS. Additionally, heat-shock protein co-inducers, similar to arimoclomol, are being explored for their potential to help ALS patients by promoting cell stress responses. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for people with ALS who've had symptoms start within the last 3 years and can swallow solids. They need a reliable caregiver, no recent drug abuse, or severe cognitive issues. Participants should not be using certain ALS treatments like diaphragmatic pacing or have been in stem cell studies for ALS.

Inclusion Criteria

I can swallow solid foods.

My first ALS symptoms appeared less than 3 years ago.

I do not have an active COVID-19 infection.

Exclusion Criteria

You are currently using or planning to use a diaphragmatic pacing device during the study.

Known to have received any investigational product within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study

History of clinically significant medical conditions (other than ALS) or any other reason, including any physical, psychological, or psychiatric condition that, in the opinion of the Investigator, would compromise the safety or interfere with the subject's participation in the study, or would make the subject an unsuitable candidate to receive study drug, or would put the subject at risk by participating in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week, randomized, double-blind, placebo-controlled study to assess safety, tolerability, and pharmacokinetics of Fosigotifator

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Active Treatment Extension

Participants receive Fosigotifator for up to 152 weeks in an open-label extension to further assess long-term safety and tolerability

152 weeks

Treatment Details

Interventions

• ABBV-CLS-7262
• Placebo

Trial Overview ABBV-CLS-7262, a new potential treatment for ALS, is being tested against a placebo over up to 156 weeks. Initially, there's a 4-week double-blind phase where participants won't know if they're getting the real drug or placebo, followed by an active treatment extension where all get ABBV-CLS-7262.

Participant Groups

Group I: Fosigotifator Medium Dose Active Control 1 Intervention

Group II: Fosigotifator High Dose Active Control 1 Intervention

Group III: Fosigotifator Low Dose Active Control 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Calico Life Sciences LLC

Industry Sponsor

Trials

11

Recruited

960+

Findings from Research

The ALSUMMIT trial is a phase III study involving 115 participants to evaluate the long-term efficacy and safety of intrathecal autologous bone marrow-derived mesenchymal stem cells (BM-MSCs) in patients with ALS, comparing a single-cycle treatment with additional booster injections against a control group.

Initial results from a previous study indicated that a single cycle of BM-MSC treatment was safe and provided benefits for up to 6 months, but the ALSUMMIT trial aims to determine if the addition of booster injections can enhance long-term outcomes beyond this period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Lenzumestrocel (Neuronata-R® inj.) in patients with amyotrophic lateral sclerosis (ALSUMMIT study): study protocol for a multicentre, randomized, double-blind, parallel-group, sham procedure-controlled, phase III trial. Nam, JY., Lee, TY., Kim, K., et al.[2023]

A review of 53 new drugs evaluated in clinical trials for ALS from 2020 to 2022 identified five promising candidates, including AMX0035, which has recently been approved by the FDA, marking it as the third drug approved for ALS treatment after riluzole and edaravone.

The review categorized these drugs into eight mechanistic groups, highlighting a diverse range of approaches being explored to combat ALS, with 13 drugs currently in phase 3 trials, indicating ongoing efforts to find more effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments and opportunities in drugs being trialed for amyotrophic lateral sclerosis from 2020 to 2022. Jiang, J., Wang, Y., Deng, M.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled trial of arimoclomol in rapidly progressive SOD1 ALS. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Lenzumestrocel (Neuronata-R® inj.) in patients with amyotrophic lateral sclerosis (ALSUMMIT study): study protocol for a multicentre, randomized, double-blind, parallel-group, sham procedure-controlled, phase III trial. [2023]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Clinical trials for neuroprotection in ALS. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

New developments and opportunities in drugs being trialed for amyotrophic lateral sclerosis from 2020 to 2022. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Edaravone efficacy in amyotrophic lateral sclerosis with reduced forced vital capacity: Post-hoc analysis of Study 19 (MCI186-19) [clinical trial NCT01492686]. [2022]