Recruiting
Phase 1

Anakinra

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT06974877

Conditions

Cryopyrin-Associated Periodic Syndromes

Amyloidosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

124I AT-01

Study Details

Brief summary:

Background:

Anakinra is a drug used to treat people with certain diseases that affect their immune systems. Sometimes anakinra can cause proteins under the skin to clump together. These clumps are called amyloidosis; they can spread to other organs. The only way to diagnose amyloidosis is to remove a piece of tissue (biopsy). Researchers want to find a way to locate amyloidosis in internal organs using positron emission tomography (PET)/computed tomography (CT).

Objective:

To test a new tracer used during PET/CT scans in people with amyloidosis. A tracer is a radioactive dye injected into the body.

Eligibility:

Adults aged 18 years or older with amyloidosis from anakinra injections. They must be enrolled in NIH protocol 17-I-0016.

Design:

Participants will come to the clinic once every 6 months for 2 years. Each visit will be 1 day.

They will have a PET/CT scan with the new tracer at each visit: The tracer will be given through a tube attached to a needle inserted into a vein.

The PET/CT scanner is a machine shaped like a doughnut. Participants will lie still on a padded table. The table will move in and out of the machine. The scan takes about 1 hour.

Radiation from the tracer will remain in the body for 24 hours after each scan. Participants will need to follow rules to avoid exposing pets and other people.

Participants will collect a 24-hour urine sample before each visit. They will also have blood tests and a physical exam at each visit.

Participants will receive a follow-up phone call about 1 week after each visit.

Conditions

Cryopyrin-Associated Periodic Syndromes

Amyloidosis

Study ID

NCT06974877

Start date

Sep 10, 2025

Status verified date

May 14, 2026

Completion date

Jan 31, 2032

Anticipated

Primary completion date

Jul 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

An individual must meet all the following criteria to be eligible for this study:

1. Aged 18 years and older.
2. Currently enrolled on NIH protocol 17-I-0016 with a documented diagnosis of MWS or NOMID.
3. Agree to allow data collected in this study to be shared with and stored on NIH protocol 17-I-0016 for that study s research analyses.
4. Developed skin thickening at the site of anakinra injection.
5. Participants who can become pregnant or who can impregnate their partner must agree to use 2 highly effective methods of contraception, at least 1 of which must be a barrier method, when engaging in sexual activities that can result in pregnancy, beginning 28 days prior to baseline until 90 days after the last PET/CT scan. Acceptable methods of contraception include the following:

1. Barrier methods:

  • External or internal condom with spermicide.
  • Diaphragm or cervical cap with a spermicide.
2. Non-barrier methods:

  • Hormonal contraception.
  • Intrauterine device.
  • Hysterectomy, oophorectomy, or tubal ligation in women
  • Vasectomy in men
3. Other.

EXCLUSION CRITERIA:

1. Known hypersensitivity to 124I-AT-01, AT-01, or any of their excipients.
2. Known hypersensitivity to KI.
3. Pregnant or breastfeeding.
4. Currently receiving dialysis.
5. Currently taking heparin or heparin derivatives (eg, low molecular weight heparins) or other blood thinners for anticoagulation.
6. Any condition that, in the opinion of the study team, contraindicates participation in this study.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Interventional

Participants aged 18 years and older with anakinra-type amyloidosis (n=10) will be recruited from NIH protocol 17-I-0016. Upon confirmation of eligibility, they will undergo a PET/CT scan with the investigational radiotracer 124I-AT-01, which selectively binds to amyloid fibers. Blood and urine will also be collected for clinical and research analyses, including measurement of IL-1RA and other biomarkers. These scans and sample collections will be repeated about once every 6 months for 2 years.

Interventions

124I AT-01

124I-AT-01 is an amyloid-reactive synthetic 45-L amino acid polypeptide radiolabeled with iodine-124, with a theoretical molecular weight of 4763.6 Da (based on amino acid sequence). The polypeptide, AT-01, is not pharmacologically active. 124I-AT-01 binds many forms of human and murine amyloid and is intended to be a PET imaging agent for the detection of amyloid deposits.

Primary outcome measure

  • Change in organ-specific 124I AT-01 uptake from baseline PET/CT imaging to the follow up PET/CT imaging every 6 months for 2 years. [ Time Frame: 2 years ]
  • Frequency of CAPS disease flares after exposure to 124I AT 01. [ Time Frame: Through end of study. ]

Central Contacts and Locations

Central contacts

Sara Alehashemi, M.D.

(000) 000-0000sara.alehashemi@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

Sara Alehashemi, M.D.

(301) 761-7570sara.alehashemi@nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

May 19, 2026

Last verified

May 14, 2026

Keywords

  • Muckle-Wells Syndrome
  • Neonatal Onset Multisystem Inflammatory Disease
  • Interleukin 1 Receptor Antagonist Protein
  • Anakinra
  • AMYLOIDOSIS
  • AIL1RAP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-05-19.