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A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)

Sponsored by Amgen

Quick Self-Assessment

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 12, 2026

Phase

Clinical Trial

Sponsor

Amgen

Enrollment Target

844

Start Date

Feb 2025

📊
1 of 844 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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

Who Can Participate

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 proced

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

📋

Study Type

INTERVENTIONAL

👥

Target Enrollment

844 participants

Gender

ALL

🏢

Sponsor

Amgen

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Avondale

Arizona

Location available
RECRUITING

Flagstaff

Arizona

Location available
RECRUITING

Gilbert

Arizona

Location available
RECRUITING

Glendale

Arizona

Location available
RECRUITING

Tucson

Arizona

Location available
RECRUITING

Covina

California

Location available
RECRUITING

La Jolla

California

Location available
RECRUITING

Fort Collins

Colorado

Location available
RECRUITING

Bradenton

Florida

Location available

📍 And 21 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

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Looking for Sjögren's Syndrome Treatment in Flagstaff?

Join others in Arizona exploring innovative treatment options through clinical research

Sjögren's Syndrome Treatment Options in Flagstaff, Arizona

If you're searching for Sjögren's Syndrome treatment in Flagstaff, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Flagstaff, Gilbert, Glendale and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Sjögren's Syndrome. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 844 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Sjögren's Syndrome?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Sjögren's Syndrome

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Sjögren's Syndrome Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06747949. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.