Baricitinib for Job Syndrome

Overseen By Alexandra F Freeman, M.D.

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: JAK inhibitors, DMARDs

Disqualifiers: HIV, Hepatitis B, Cancer, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 9

Duration: 6 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if baricitinib, a drug used for other immune issues, can benefit individuals with Job syndrome, a rare condition affecting the immune system. Job syndrome can cause skin rashes and lupus-like symptoms. The trial targets those with these symptoms alongside Job syndrome. Participants will take baricitinib daily in a controlled setting to assess its effectiveness. Individuals with Job syndrome who experience lupus-like symptoms or persistent skin rashes might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

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

Research has shown that baricitinib is generally safe for people. In a study with 1,303 patients who took baricitinib for about 532 days, the treatment proved mostly safe. Common side effects were mild, including colds or minor infections.

The FDA has already approved baricitinib for other immune system issues, indicating its safety for those uses. However, as with any medication, individual reactions may vary.

In this study for Job Syndrome, the treatment begins with a low dose to assess tolerance and can be adjusted if necessary. Discuss any concerns with a doctor before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Baricitinib is unique because it works differently from most treatments for Job Syndrome, which typically include antibiotics, antifungals, or immunoglobulin therapy. While standard treatments focus on managing infections and symptoms, Baricitinib is a Janus kinase (JAK) inhibitor that targets specific pathways involved in immune system regulation. This targeted approach could potentially offer a more precise method of addressing the underlying immune dysfunction in Job Syndrome, which is why researchers are excited about its potential.

What evidence suggests that baricitinib might be an effective treatment for Job syndrome?

Research shows that baricitinib, a type of medication, might help treat Job syndrome. In earlier studies, patients with similar immune system issues felt better and experienced less pain after taking baricitinib. One study found that about 70.5% of patients had low disease activity, and 60.7% had no symptoms at all. Another report showed a patient with a similar immune condition experienced complete symptom relief. These findings suggest that baricitinib could help manage symptoms in people with Job syndrome, especially those with lupus-like symptoms or skin rashes. Participants in this trial will receive baricitinib to evaluate its effectiveness for Job syndrome. ^{5 6 7 8 9}

Who Is on the Research Team?

Alexandra F Freeman, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Are You a Good Fit for This Trial?

This trial is for people aged 12 and older with Job syndrome, who also have lupus-like disease or atopic dermatitis (skin rash). Participants will be involved in the study for 9 months, which includes clinic visits, remote check-ins, and phone calls.

Inclusion Criteria

* INCLUSION CRITERIA

1. Must be able to understand and provide informed consent or assent.

2. Aged \>=12 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 months

2 phone calls

Lead-in

Participants continue with their usual medical care and monitor disease activity

3 months

2 phone calls

Treatment

Participants receive baricitinib treatment, starting with a low dose and possibly increasing to a higher dose

6 months

5 clinic visits, 4 remote visits, 2 phone visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Baricitinib

Trial Overview Researchers are testing baricitinib—a drug already approved for other immune conditions—to see if it can help patients with Job syndrome. The treatment involves taking a tablet daily for 6 months, starting with a low dose that may increase.

How Is the Trial Designed?

Group I: Interventional Experimental Treatment 1 Intervention

baricitinib

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07262983

Evaluating the Safety and Tolerability of Baricitinib in ... Primary Objective: To determine the safety and tolerability of JAK inhibitor treatment (baricitinib) in patients with Job s syndrome with lupus-like disease and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8964893/

Real-World Treatment Patterns and Clinical Outcomes of ... Nevertheless, high persistence and improvements in disease activity and pain were found at 6 and 12 months after treatment initiation, ...

3. researchgate.net researchgate.net/publication/380110026_The_Real-World_Effectiveness_Persistence_Adherence_and_Safety_of_Janus_Kinase_Inhibitor_Baricitinib_in_Rheumatoid_Arthritis_A_Long-Term_Study

The Real-World Effectiveness, Persistence, Adherence, ... 70.5% and 60.7% of patients achieved low disease activity or remission, respectively, and 50.8% (31/61) remained on BAR throughout the follow-up ...

4. frontierspartnerships.org frontierspartnerships.org/journals/journal-of-cutaneous-immunology-and-allergy/articles/10.3389/jcia.2024.12455/full

Real-world effectiveness and safety of baricitinib including its ... Objective severity scores and patient-reported outcomes improved at one and 3 months, except for the affected body surface area at 1 month. The ...

5. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2806331

Hyperactivation of the JAK2/STAT5 Signaling Pathway and ... In 1 index patient, treatment with baricitinib (a Janus kinase JAK1/JAK2 inhibitor) was associated with complete clinical remission of ...

6. clinicalstudies.info.nih.gov clinicalstudies.info.nih.gov/protocoldetails.aspx?id=002176-I&&query=

Protocol Details A Pilot Study to Evaluate the Safety and Tolerability of Baricitinib in Patients with Job s Syndrome with Lupus-like Disease and/or Atopic Dermatitis. This ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2018/207924Orig1s000SumR.pdf

207924Orig1s000 - accessdata.fda.gov While the limited safety database with 2 mg does introduce uncertainty, the dose related pharmacodynamic changes, including laboratory ...

8. clinicalstudies.info.nih.gov clinicalstudies.info.nih.gov/htmlSearchedFile.aspx?Query=Hyper-Ige%20Syndrome%205,%20Autosomal%20Recessive,%20with%20Recurrent%20Infections&status=&gender=Select%20One&Inst=&age=&healthyVolunteer=0

NIH Clinical Center: Search the Studies A Pilot Study to Evaluate the Safety and Tolerability of Baricitinib in Patients with Job s Syndrome with Lupus-like Disease and/or Atopic Dermatitis ...

9. academic.oup.com academic.oup.com/bjd/article/188/2/218/6821292

Integrated safety analysis of baricitinib in adults with severe ... Data were collected for 1303 patients who were given baricitinib, reflecting 1868 patient-years of exposure (median 532 days). The most frequently reported ...