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Cytokine Therapy

Low Dose for Alopecia Areata

Phase 2

Recruiting

Research Sponsored by Nektar Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 52 and 60.

Awards & highlights

Study Summary

"This trial aims to study the effects of a drug called pegylated-recombinant-human interleukin-2 in adults with severe to very severe alopecia areata. The study will last

Who is the study for?

This clinical trial is for adults with severe to very severe alopecia areata. Participants must complete a screening, undergo treatment for 36 weeks, and participate in follow-up for another 24 weeks. Specific eligibility criteria details were not provided.Check my eligibility

What is being tested?

The study tests Rezpegaldesleukin (Rezpeg), a form of pegylated-recombinant-human interleukin-2, against a placebo to see its effect on alopecia areata. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real treatment or placebo.See study design

What are the potential side effects?

Potential side effects of Rezpegaldesleukin were not detailed in the information provided. Typically, side effects could range from mild reactions at injection sites to more significant immune-related responses due to its nature as an interleukin-2 therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 52 and 60.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 52 and 60.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 52 and 60. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36

Secondary outcome measures

Percent change from baseline in SALT score

Proportion of patients achieving an absolute SALT score ≤ 10/20/30

Proportion of patients achieving improvement in Severity of Alopecia Tool (SALT) ≥ 50%/75%/90%

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low DoseExperimental Treatment1 Intervention

Rezpegaldesleukin Low Dose Every 2 weeks

Group II: High DoseExperimental Treatment1 Intervention

Rezpegaldesleukin High Dose Every 2 weeks

Group III: PlaceboPlacebo Group1 Intervention

Placebo Every 2 weeks

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nektar TherapeuticsLead Sponsor

58 Previous Clinical Trials

10,232 Total Patients Enrolled

Study DirectorStudy DirectorNektar Therapeutics

1,212 Previous Clinical Trials

499,162 Total Patients Enrolled

1 Trials studying Alopecia Areata

13 Patients Enrolled for Alopecia Areata

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study allow individuals who are at least 18 years old to participate?

"Participants eligible for enrollment must be above 18 years of age and below 70 years old."

Answered by AI

Am I eligible to enroll in this medical research study?

"Patients aged between 18 and 70 years old, diagnosed with alopecia areata, are eligible for participation in this medical trial. A total of 110 individuals will be selected to take part."

Answered by AI

Are participants being actively sought for this ongoing research study?

"Indeed, as per the details available on clinicaltrials.gov, this research study is actively seeking participants. It was originally listed on March 27th, 2024, and underwent its latest update on March 25th of the same year. The trial aims to enroll a total of 110 patients from a single designated site."

Answered by AI

How many individuals are participating in the entirety of this research endeavor?

"Affirmative. According to clinicaltrials.gov, recruitment for this trial is ongoing. The study was first listed on March 27th, 2024, and the latest update was made on March 25th, 2024. There is a need to enroll 110 participants from one designated site."

Answered by AI

What are the safety considerations for patients using Low Dose?

"On a grading scale ranging from 1 to 3, our team at Power has evaluated the safety of Low Dose as a 2. This assessment is based on the fact that this trial falls under Phase 2, indicating some existing data supporting its safety without any evidence backing up its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)

2024. "A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06340360.

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