A Multicenter, Open-Label, Long-term, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren's Syndrome (SS)

Long-term safety study of dazodalibep for Sjögren's Syndrome patients

NCT: NCT06747949 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Amgen · Started: 2025-02-25 · Est. Completion: 2029-12-11

Plain English Summary

A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) is a Phase 3 clinical trial sponsored by Amgen studying Sjögren's Syndrome. This study tests the long-term safety and tolerability of a drug called dazodalibep. It is for adults with Sjögren's Syndrome who have already participated in a previous dazodalibep Phase 3 study. Participation involves receiving dazodalibep intravenously (IV) and attending regular study visits. The alternative for patients not in this study is to continue with their current standard care for Sjögren's Syndrome. The trial aims to enroll 844 participants.

Official Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with Sjögren's Syndrome who have completed a prior dazodalibep Phase 3 study (HZNP-DAZ-301 or HZNP-DAZ-303) and received the study drug. Must be able to attend study visits and receive the study drug within a specific timeframe after their previous study. Cannot have active infections, be planning other clinical studies, or have health conditions that could interfere with safety evaluations. Women who are pregnant, breastfeeding, or unwilling to use contraception are excluded. This trial is studying Sjögren's Syndrome, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how many participants experience any new or worsening side effects over a long period, indicating the drug's overall safety profile. The specific primary outcome measures are: Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Up to 152 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial matters because it aims to understand the long-term safety of dazodalibep, a potential new treatment option for Sjögren's Syndrome, addressing the need for sustained symptom management. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Sjögren's Syndrome, where improved treatment options are needed.

Investor Insight

This Phase 3 extension study signals strong confidence from sponsor Amgen in dazodalibep's potential, suggesting a competitive landscape for Sjögren's Syndrome treatments and a potentially favorable p Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 844 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you qualify based on your previous participation in dazodalibep studies. Understand that participation involves regular IV infusions of dazodalibep and multiple study visits over several years. Be prepared to report any new health issues or side effects promptly to the study team. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria apply:

* Participant has provided informed consent before initiation of any study specific activities/procedures.
* Must have been eligible to receive and have received IP (dazodalibep or placebo) and completed the study (through Week 48) in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303).
* Must be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) for the prior pivotal phase 3 SS dazodalibep studies (HZNP DAZ-301, or HZNP DAZ-303).

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Clinically significant active infection at Day 1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication.
* Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in observational research studies while participating in this study are excluded.
* Any condition or change in health status observed or reported during the phase 3 SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety or alter the risk-benefit associated with IP administration.
* Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety.
* Individuals who plan to receive live (attenuated) vaccine during the LTE study.
* Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 weeks after the last dose of investigational product.
* Female participants who are pregnant or lactating or planning to become pregnant during the study.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
* History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06747949?

NCT06747949 is a Phase 3 INTERVENTIONAL study titled "A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)." It is currently recruiting and is sponsored by Amgen. The trial targets enrollment of 844 participants.

What conditions does NCT06747949 study?

This trial investigates treatments for Sjögren's Syndrome. The primary condition under study is Sjögren's Syndrome.

What treatments are being tested in NCT06747949?

The interventions being studied include: Dazodalibep (DRUG). Dazodalibep will be given intravenously (IV).

What does Phase 3 mean for NCT06747949?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06747949?

This trial is currently "Recruiting." It started on 2025-02-25. The estimated completion date is 2029-12-11.

Who is sponsoring NCT06747949?

NCT06747949 is sponsored by Amgen. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06747949?

The trial aims to enroll 844 participants. The trial is currently recruiting and accepting new participants.

How is NCT06747949 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT06747949?

The primary outcome measures are: Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Up to 152 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06747949 being conducted?

This trial is being conducted at 20 sites, including Avondale, Arizona; Flagstaff, Arizona; Gilbert, Arizona; Glendale, Arizona and 16 more sites (United States).

Where can I find official information about NCT06747949?

The official record for NCT06747949 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06747949. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06747949 testing in simple terms?

This study tests the long-term safety and tolerability of a drug called dazodalibep. It is for adults with Sjögren's Syndrome who have already participated in a previous dazodalibep Phase 3 study.

Why is this trial significant?

This trial matters because it aims to understand the long-term safety of dazodalibep, a potential new treatment option for Sjögren's Syndrome, addressing the need for sustained symptom management. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06747949?

The most common risks involve treatment-emergent adverse events, which are side effects that appear during the study. Potential side effects could include reactions at the infusion site or other general adverse events, which will be closely monitored. There is a risk of developing anti-drug antibodies, which could affect how well the medication works. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06747949?

Ask your doctor if you qualify based on your previous participation in dazodalibep studies. Understand that participation involves regular IV infusions of dazodalibep and multiple study visits over several years. Be prepared to report any new health issues or side effects promptly to the study team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06747949 signal from an investment perspective?

This Phase 3 extension study signals strong confidence from sponsor Amgen in dazodalibep's potential, suggesting a competitive landscape for Sjögren's Syndrome treatments and a potentially favorable p This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participation involves receiving dazodalibep intravenously (IV) and attending regular study visits. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.