Alopecia AreataPhase 1NCT06545110
Retinol Binding Protein 4 Protein in Alopecia Areata Treated With Barcitinib
A Phase 1 study testing Baricitinib Oral Tablet in people with Alopecia Areata, run by South Valley University at 1 site in Egypt.
Trial summary
Assess serum and tissue retinol binding protein 4 in patients with severe alopecia areata in correlation with healthy individuals . Estimate genetic profile of retinol binding protein4 in severe alopecia areata patients Assess possible role of retinol binding protein 4 genetic mutation in response to barcitinib… Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Baricitinib Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 30 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients at least 12 years old not more than 60 with severe alopecia areata, multiple or /with not responding to usual treatment
Who cannot join
- Patients with scarring alopecia.
- Patients less than 12 years old or more than 60.
- Patients with active inflammatory disease or immuncompromised.
- Patients with infection or malignancy .
- Patients with antiepileptic drugs or psychotics .
- Pregnancy and lactation .
Show all 10Show fewer
- Patients with abnormal lipid profile.
- Patients with bleeding or thrombotic tendency.
- Patients taking other JAK inhibitors or cyclosporine or immunosuppressive drugs.
- Patients with active herpes zoster or have tendency for recurrence.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Valley University
Qina, الكيلو 6 Qena - Safaga Rd, Qena, Qena Governorate, +20963211279
About this study
Official title: Retinol Binding Protein 4 Expression and Its Genetic Variants in Severe Alopecia Areata Treated With Barcitinib.
Assess serum and tissue retinol binding protein 4 in patients with severe alopecia areata in correlation with healthy individuals .
Estimate genetic profile of retinol binding protein4 in severe alopecia areata patients
Assess possible role of retinol binding protein 4 genetic mutation in response to barcitinib treatment in patients with severe alopecia areata .
Read the detailed description
Alopecia areata is an autoimmune disorder characterized by transient, non-scarring hair loss and preservation of the hair follicle .It is a multifactorial disease in which environmental, neuro-endocrinological, immunological and genetic factors are involved . AA affecting the hair follicle is the most common form, through a breakdown in immune privilege of the hair follicle in the anagen (hair growth) phase by CD4+ and CD8+ T lymphocytes .
Based on the degree of hair loss and variation in clinical presentation, AA classified into patchy (AA; localized areas of hair loss on the scalp and/or body), totalis (AT; entire scalp hair loss), and universalis (AU; entire scalp and body hair loss . Several studies showed that genes involved in immune response , inflammatory diseases . infectious diseases .The hair loss in AA involves changes in the hair growth cycle, resulting in dystrophic anagen hair follicles together with increased frequency of telogen follicles.
Retinol binding protein 4 (RBP4) is a member of the lipocalin family and the major transport protein of the hydrophobic molecule retinol, also known as vitamin A, in the circulation. Expression of RBP4 is highest in the liver, where most of the body's vitamin A reserves are stored as retinyl esters. For the mobilization of vitamin A from the liver, retinyl esters are hydrolyzed to retinol, which then binds to RBP4 in the hepatocyte . The pathogenesis of AA may be related to increased serum retinol-binding protein-4 (RBP4) level. Its level was found to be increasing in the outer root sheath during late anagen and remained as such throughout catagen. RBP4 may contribute to inflammation by stimulating the expression of proinflammatory molecules involved in leukocyte recruitment and adherence to the endothelium .
Baricitinib (bar" i sye' ti nib) is an orally available, specific inhibitor Janus-associated kinases (mainly JAK1 and JAK2) that is used to treat moderate-to-severe rheumatoid arthritis and alopecia areata. The Janus kinases are critical steps in immune activation as well as in hematopoiesis. JAK1 is a critical kinase in the cellular responses of interferon alpha while JAK2 is involved in pathways activated by interferon gamma. The immunomodulatory effects of baricitinib have led to its evaluation in several autoimmune conditions interrupt cytokine signaling implicated in the pathogenesis of alopecia areata .
- Conditions
- Alopecia Areata
- Being tested
- Baricitinib Oral Tablet
- Keywords
- Retinol binding protein 4 , Barcitinib
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib Oral TabletDrug
Baricitinib 2/4mg giving to patients with sever alopecia areata after assessment Retinol Binding Protein 4 and its genetic variations.
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | 60 patient with sever alopecia areata Receives: Drug: Baricitinib Oral Tablet |
| group B | Placebo comparator | 60 healthy individuals Receives: Drug: Baricitinib Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess serum and tissue retinol binding protein 4 in patients with severe alopecia
Assess serum and tissue retinol binding protein 4 in patients with severe alopecia in serum and tissue samples in response to Baricitinib .
Measured: baseline
Secondary outcomes (1)
Estimate genetic profile of retinol binding protein4 in severe alopecia areata patients
Estimate genetic variations of Retinol binding protein 4 in blood samples before and after Baricitinib.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Sep 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Alyan Abd-elaziz Mohammed, South Valley University
- Investigators
- Mostafa Adam Ali El Tieb, professor, Study director, Aswan UniversityMohamed Hosny Hassan, professor, Study director, South Valley UniversityEisa Mohammed Hegazy, professor, Study director, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545110
- Sponsor's protocol ID
- RBP4 in alopecia areata
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, Hordinsky M, Dutronc Y, Wu WS, McCollam J, Chiasserini C, Yu G, Stanley S, Holzwarth K, DeLozier AM, Sinclair R; BRAVE-AA Investigators. Two Phase 3 Trials of Baricitinib for Alopecia Areata. N Engl J Med. 2022 May 5;386(18):1687-1699. doi: 10.1056/NEJMoa2110343. Epub 2022 Mar 26.
PubMed 35334197Steinhoff JS, Lass A, Schupp M. Biological Functions of RBP4 and Its Relevance for Human Diseases. Front Physiol. 2021 Mar 11;12:659977. doi: 10.3389/fphys.2021.659977. eCollection 2021.
PubMed 33790810Al-Eitan LN, Alghamdi MA, Al Momani RO, Aljamal HA, Abdalla AM, Mohammed HM. Genetic predisposition of alopecia areata in jordanians: A case-control study. Heliyon. 2022 Mar 24;8(4):e09184. doi: 10.1016/j.heliyon.2022.e09184. eCollection 2022 Apr.
PubMed 35392398Bhardwaj P, Basu D, Podder I, Gharami RC. Clinico-Epidemiological Profile of Childhood Alopecia Areata Along with Dermoscopic Correlation: A Cross-Section, Observational Study. Indian Dermatol Online J. 2021 Mar 2;12(2):250-257. doi: 10.4103/idoj.IDOJ_451_20. eCollection 2021 Mar-Apr.
PubMed 33959521Gil-Quinones SR, Sepulveda-Pachon IT, Sanchez Vanegas G, Gutierrez-Castaneda LD. Effect of PTPN22, FAS/FASL, IL2RA and CTLA4 genetic polymorphisms on the risk of developing alopecia areata: A systematic review of the literature and meta-analysis. PLoS One. 2021 Nov 4;16(11):e0258499. doi: 10.1371/journal.pone.0258499. eCollection 2021.
PubMed 34735462Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017 Mar 16;3:17011. doi: 10.1038/nrdp.2017.11.
PubMed 28300084
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinol Binding Protein 4 Expression and Its Genetic Variants in Severe Alopecia Areata Treated With Barcitinib.
- ClinicalTrials.gov ID
- NCT06545110
- Acronym / sponsor ID
- RBP4 in alopecia areata
- Conditions
- Alopecia Areata
- Keywords
- Retinol binding protein 4 , Barcitinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess serum and tissue retinol binding protein 4 in patients with severe alopecia areata in correlation with healthy individuals .
Estimate genetic profile of retinol binding protein4 in severe alopecia areata patients
Assess possible role of retinol binding protein 4 genetic mutation in response to barcitinib treatment in patients with severe alopecia areata .
Detailed description
Alopecia areata is an autoimmune disorder characterized by transient, non-scarring hair loss and preservation of the hair follicle .It is a multifactorial disease in which environmental, neuro-endocrinological, immunological and genetic factors are involved . AA affecting the hair follicle is the most common form, through a breakdown in immune privilege of the hair follicle in the anagen (hair growth) phase by CD4+ and CD8+ T lymphocytes .
Based on the degree of hair loss and variation in clinical presentation, AA classified into patchy (AA; localized areas of hair loss on the scalp and/or body), totalis (AT; entire scalp hair loss), and universalis (AU; entire scalp and body hair loss . Several studies showed that genes involved in immune response , inflammatory diseases . infectious diseases .The hair loss in AA involves changes in the hair growth cycle, resulting in dystrophic anagen hair follicles together with increased frequency of telogen follicles.
Retinol binding protein 4 (RBP4) is a member of the lipocalin family and the major transport protein of the hydrophobic molecule retinol, also known as vitamin A, in the circulation. Expression of RBP4 is highest in the liver, where most of the body's vitamin A reserves are stored as retinyl esters. For the mobilization of vitamin A from the liver, retinyl esters are hydrolyzed to retinol, which then binds to RBP4 in the hepatocyte . The pathogenesis of AA may be related to increased serum retinol-binding protein-4 (RBP4) level. Its level was found to be increasing in the outer root sheath during late anagen and remained as such throughout catagen. RBP4 may contribute to inflammation by stimulating the expression of proinflammatory molecules involved in leukocyte recruitment and adherence to the endothelium .
Baricitinib (bar" i sye' ti nib) is an orally available, specific inhibitor Janus-associated kinases (mainly JAK1 and JAK2) that is used to treat moderate-to-severe rheumatoid arthritis and alopecia areata. The Janus kinases are critical steps in immune activation as well as in hematopoiesis. JAK1 is a critical kinase in the cellular responses of interferon alpha while JAK2 is involved in pathways activated by interferon gamma. The immunomodulatory effects of baricitinib have led to its evaluation in several autoimmune conditions interrupt cytokine signaling implicated in the pathogenesis of alopecia areata .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: Baricitinib Oral Tablet60 patient with sever alopecia areata |
| group B | Placebo comparator | Drug: Baricitinib Oral Tablet60 healthy individuals |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients at least 12 years old not more than 60 with severe alopecia areata, multiple or /with not responding to usual treatment
Key exclusion criteria (10 listed)
- Patients with scarring alopecia.
- Patients less than 12 years old or more than 60.
- Patients with active inflammatory disease or immuncompromised.
- Patients with infection or malignancy .
- Patients with antiepileptic drugs or psychotics .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baricitinib Oral TabletBaricitinib 2/4mg giving to patients with sever alopecia areata after assessment Retinol Binding Protein 4 and its genetic variations. | Drug | group A, group B |
Primary outcome
Assess serum and tissue retinol binding protein 4 in patients with severe alopecia
Time frame: baseline
Assess serum and tissue retinol binding protein 4 in patients with severe alopecia in serum and tissue samples in response to Baricitinib .
1 secondary outcome
Estimate genetic profile of retinol binding protein4 in severe alopecia areata patients
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 35334197King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, Hordinsky M, Dutronc Y, Wu WS, McCollam J, Chiasserini C, Yu G, Stanley S, Holzwarth K, DeLozier AM, Sinclair R; BRAVE-AA Investigators. Two Phase 3 Trials of Baricitinib for Alopecia Areata. N Engl J Med. 2022 May 5;386(18):1687-1699. doi: 10.1056/NEJMoa2110343. Epub 2022 Mar 26.
- Background: PubMed 33790810Steinhoff JS, Lass A, Schupp M. Biological Functions of RBP4 and Its Relevance for Human Diseases. Front Physiol. 2021 Mar 11;12:659977. doi: 10.3389/fphys.2021.659977. eCollection 2021.
- Background: PubMed 35392398Al-Eitan LN, Alghamdi MA, Al Momani RO, Aljamal HA, Abdalla AM, Mohammed HM. Genetic predisposition of alopecia areata in jordanians: A case-control study. Heliyon. 2022 Mar 24;8(4):e09184. doi: 10.1016/j.heliyon.2022.e09184. eCollection 2022 Apr.
- Background: PubMed 33959521Bhardwaj P, Basu D, Podder I, Gharami RC. Clinico-Epidemiological Profile of Childhood Alopecia Areata Along with Dermoscopic Correlation: A Cross-Section, Observational Study. Indian Dermatol Online J. 2021 Mar 2;12(2):250-257. doi: 10.4103/idoj.IDOJ_451_20. eCollection 2021 Mar-Apr.
- Background: PubMed 34735462Gil-Quinones SR, Sepulveda-Pachon IT, Sanchez Vanegas G, Gutierrez-Castaneda LD. Effect of PTPN22, FAS/FASL, IL2RA and CTLA4 genetic polymorphisms on the risk of developing alopecia areata: A systematic review of the literature and meta-analysis. PLoS One. 2021 Nov 4;16(11):e0258499. doi: 10.1371/journal.pone.0258499. eCollection 2021.
- Background: PubMed 28300084Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017 Mar 16;3:17011. doi: 10.1038/nrdp.2017.11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa Adam Ali El Tieb, professor study director
Aswan University
Mohamed Hosny Hassan, professor study director
South Valley University
Eisa Mohammed Hegazy, professor study director
South Valley University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Baricitinib Oral Tablet in people with Alopecia Areata, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess serum and tissue retinol binding protein 4 in patients with severe alopecia (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545110, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.