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Investigational drug AMG 335 offered to adults with IgG4-Related disease

NCT ID NCT06590051

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved This study
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

This expanded access program allows adults with a confirmed diagnosis of IgG4-related disease to request the investigational drug AMG 335, also known as UPLIZNA. IgG4-related disease is a rare condition where the immune system causes inflammation and swelling in organs. The program is run by Amgen and is not a clinical trial, so it does not compare the drug to a placebo. Patients or their doctors contact the sponsor to ask about access.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an investigational drug called AMG 335, also known as UPLIZNA
What this could lead to
If it helps, this program could give adults with IgG4-related disease a way to receive an investigational treatment when no standard option works for them.
What could go wrong
Expanded access programs are not formal trials, so they collect limited safety and benefit information. The drug may not work for everyone, and it can carry side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

immunoglobulin G4-related sclerosing disease

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