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Baricitinib High Dose for Alopecia Areata

Skin Care Research, Inc, Boca Raton, FL
Alopecia Areata+8 More ConditionsBaricitinib - Drug
Eligibility
6 - 17
All Sexes
What conditions do you have?
Select

Study Summary

This trial will determine the effectiveness and safety of Baricitinib to treat hair loss in children 6-18 years old.

Eligible Conditions
  • Alopecia Areata
  • Skin Diseases
  • Pathological Anatomy
  • Hair Loss
  • Alopecia

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
SADBE 5%
1
Ritlecitinib 20 mg
1
Dupilumab

Study Objectives

1 Primary · 26 Secondary · Reporting Duration: Pre-Vaccination to 4 Weeks and 12 Weeks Post-Vaccination

Baseline through Week 36
PK: Area Under the Concentration Curve (AUC)
Pharmacokinetics (PK): Maximum Concentration (Cmax)
Baseline, Week 36
Mean Change From Baseline in SALT Score
Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI)
Mean Change from Baseline in Family Dermatology Life Quality Index (FLDQI)
Mean Change from Baseline in PROMIS Depression Score
Mean Change from Baseline in PROMIS Peer Relationship Score
Mean Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety Score
Mean Change from Baseline in SALT Score
Percent Change From Baseline in SALT Score
Percent Change from Baseline in SALT Score
Week 12
Change of Immunoglobulin G (IgG) Titers
Week 36
Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS)
Percentage of Participants Achieving At Least 100% Improvement from Baseline (SALT100)
Percentage of Participants Achieving At Least 50% Improvement from Baseline (SALT50)
Percentage of Participants Achieving At Least 75% Improvement from Baseline (SALT75)
Percentage of Participants Achieving At Least 90% Improvement from Baseline (SALT90)
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EL Hair Loss ≥2 at Baseline
Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 Among Participants with CLinRO Measure for EB Hair Loss ≥2 at Baseline
Percentage of Participants Achieving PRO Measure for EB 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EB ≥2 at Baseline)
Percentage of Participants Achieving PRO Measure for EB 0 or 1 (Among Participants with PRO Measure for EB ≥2 at Baseline)
Percentage of Participants Achieving PRO Measure for EL 0 or 1 (Among Participants 12 Years or Older with PRO Measure for EL ≥2 at Baseline)
Percentage of Participants Achieving PRO Measure for EL 0 or 1 (Among Participants with PRO Measure for EL ≥2 at Baseline)
Percentage of Participants Achieving an Absolute SALT ≤10
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) ≤20
Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1
Percentage of Participants with Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 Among Participants 12 Years and Older with PRO for Scalp Hair Assessment Score ≥3 at Baseline

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
SADBE 5%
1
Ritlecitinib 20 mg
2
Dupilumab

Side Effects for

Adalimumab Follow-up
10%Upper respiratory tract infection
6%Ovarian cyst
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT01710358) in the Adalimumab Follow-up ARM group. Side effects include: Upper respiratory tract infection with 10%, Ovarian cyst with 6%.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3 Treatment Groups

Baricitinib High Dose
1 of 3
Baricitinib Low Dose
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

595 Total Participants · 3 Treatment Groups

Primary Treatment: Baricitinib High Dose · Has Placebo Group · Phase 3

Baricitinib High Dose
Drug
Experimental Group · 1 Intervention: Baricitinib · Intervention Types: Drug
Baricitinib Low Dose
Drug
Experimental Group · 1 Intervention: Baricitinib · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
2020
Completed Phase 3
~10500

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: pre-vaccination to 4 weeks and 12 weeks post-vaccination

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,499 Previous Clinical Trials
3,154,760 Total Patients Enrolled
2 Trials studying Alopecia Areata
1,370 Patients Enrolled for Alopecia Areata
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,280 Previous Clinical Trials
381,210 Total Patients Enrolled
1 Trials studying Alopecia Areata
824 Patients Enrolled for Alopecia Areata

Eligibility Criteria

Age 6 - 17 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had severe hair loss from alopecia areata for at least one year.
You have tried at least one treatment (such as a topical medication) for AA in the past, but it did not work for you.
You have received therapy or counseling for alcohol addiction in the past.
If you have had severe AA for at least 8 years, you can still participate if you have experienced hair regrowth, either naturally or with treatment, on the affected areas within the past 8 years.
References

Frequently Asked Questions

Do individuals over the age of 35 qualify to participate in this medical research?

"Participants that wish to be part of this trial must fall between 6 and 17 years of age." - Anonymous Online Contributor

Unverified Answer

How many institutions are overseeing this trial?

"This trial has 4 currently active sites, including Total Skin and Beauty Dermatology Center in Birmingham, Clarkston Skin Research in Clarkston, Texas Dermatology and Laser Specialists in San Antonio. There are also other locations that have been approved to participate." - Anonymous Online Contributor

Unverified Answer

Has the highest dose of Baricitinib received approval from the Food and Drug Administration?

"Based on the Phase 3 trial results, there is sufficient evidence to assign a score of 3 out of 3 for Baricitinib High Dose's safety profile." - Anonymous Online Contributor

Unverified Answer

Are there any current opportunities to participate in this clinical experiment?

"The clinical trial data available on clinicaltrials.gov does not indicate that this particular study is actively recruiting patients at the moment; it was first posted on February 28th 2023 and last edited about two weeks later. However, there are currently 128 other trials across various medical areas looking for candidates to participate in their research." - Anonymous Online Contributor

Unverified Answer

What qualifications are needed for an individual to partake in this clinical trial?

"This research project seeks to enrol 595 alopecia patients, aged 6-17 years old. Eligible participants must have experienced severe AA for more than a year, current hair loss covering 50% of the scalp or higher according to SALT score, failed treatment with topical solutions and/or other treatments previously attempted, participated in psychological counselling related to their condition, and have had an episode of severe AA that has lasted less than 8 years (individuals who have suffered from it for 8+ may still be eligible if regrowth was observed over this period)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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