Dazukibart for Myositis

Recruiting at 9 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: Prohibited medications

Disqualifiers: Suicidal ideation, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 22

Duration: 48 weeks

211 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how well the medicine dazukibart works in individuals with muscle disorders called dermatomyositis (DM) and polymyositis (PM). These conditions cause muscle weakness, making activities like climbing stairs or lifting objects difficult. Participants will receive dazukibart through an IV every four weeks for about a year. The trial seeks individuals who have already participated in a previous study with dazukibart. Some participants will receive the medicine, while others will attend follow-up visits for safety monitoring. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot use any prohibited medications during the study. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that dazukibart is likely to be safe for humans?

Research has shown that dazukibart is generally well-tolerated. Earlier studies found a noticeable decrease in disease activity in patients, indicating its potential effectiveness. Importantly, dazukibart did not present any major safety issues, proving safe for most users.

In another study, patients received dazukibart every 4 weeks, as in this trial, and it was safe and manageable. Serious side effects were rare, and participants tolerated the treatment well.

This treatment is being tested in a late-stage trial, suggesting existing confidence in its safety for humans. This confidence stems from earlier studies that demonstrated its safety and tolerability. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for myositis?

Researchers are excited about dazukibart for myositis because it offers a new approach to treatment. Unlike current options, which often include corticosteroids and immunosuppressants that broadly dampen the immune system, dazukibart specifically targets key pathways involved in the inflammation process of myositis. This targeted action could mean fewer side effects and a more effective response for patients. Additionally, dazukibart is administered via intravenous infusion every four weeks, which might provide a more convenient treatment schedule compared to daily medications.

What evidence suggests that dazukibart might be an effective treatment for myositis?

Research has shown that dazukibart, the investigational treatment in this trial, can significantly reduce disease activity in muscle inflammation conditions like dermatomyositis (DM) and polymyositis (PM). Studies have found that most patients tolerate it well. Dazukibart blocks IFNβ, a protein that causes inflammation, making it promising for treating these conditions. In earlier studies, patients experienced improvements in muscle strength and fewer symptoms. This suggests that dazukibart could help people dealing with muscle weakness and inflammation from DM and PM. ^{1 2 3 4 6}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for people who have muscle inflammation diseases called DM or PM and previously participated in a dazukibart study. They must have completed the prior study through Week 52 to join.

Inclusion Criteria

I completed a study up to Week 52.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dazukibart via intravenous infusion every 4 weeks

48 weeks

18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

4 visits (in-person)

Open-label extension

Participants may opt into continuation of treatment long-term

What Are the Treatments Tested in This Trial?

Interventions

• Dazukibart

Trial Overview The trial tests how dazukibart, given as an IV infusion every 4 weeks for about a year, affects those with DM or PM. Some participants will receive this medication while others will only attend safety follow-up visits without receiving it.

How Is the Trial Designed?

Group I: Dazukibart Experimental Treatment 1 Intervention

Participants will receive dazukibart via intravenous infusion every 4 weeks.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)02071-3/abstract

Efficacy, safety, and target engagement of dazukibart, an ... Dazukibart resulted in a pronounced reduction in disease activity and was generally well tolerated, supporting IFNβ inhibition as a highly ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673624020713

Efficacy, safety, and target engagement of dazukibart, an ... Dazukibart resulted in a pronounced reduction in disease activity and was generally well tolerated, supporting IFNβ inhibition as a highly promising ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12272793/

Dazukibart for dermatomyositis: expanding the therapeutic ... In a groundbreaking study, dazukibart was evaluated in a multicenter, double-blind, placebo-controlled phase 2 trial for moderate-to-severe ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05895786

NCT05895786 | A Study to Understand How the ... The purpose of the study is to understand how the study medicine PF-06823859 (dazukibart) works in people with idiopathic inflammatory myopathies (DM and PM).

5. clinicaltrials.eu clinicaltrials.eu/inn/dazukibart/

Dazukibart – Application in Therapy and Current Clinical ... The study aims to investigate the long-term safety, tolerability, and efficacy of Dazukibart in people with active idiopathic inflammatory myopathies.

6. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/cpdd.1522

Pharmacokinetics, Safety, and Tolerability of Single‐Dose ... In a completed Phase 2 study, the safety, tolerability, and efficacy of dazukibart 150 mg and 600 mg every 4 weeks were evaluated in patients ...