Alopecia AreataPhase 3NCT06278402
Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi.
A Phase 3 study testing Tofacitinib in people with Alopecia Areata and Alopecia Totalis, run by Jinnah Hospital at 1 site in Pakistan.
Trial summary
To determine the efficacy of oral Tofacitinib in the treatment of moderate to severe alopecia areata, totalis and universalis at tertiary care hospital of Karachi, Pakistan. Efficacy of treatment in patients presenting with alopecia areata will be assessed using SALT Score on follow up at 6,12 and 24 weeks where four… Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- What is being tested?
- Tofacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2023to 16 Jan 2024
- Phase
- Phase 3
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients presenting with Alopecia areata as per operational definition will be included in the study.
- Either gender.
- Age 15 - 60 years.
Who cannot join
- Patient with history of connective tissue disorders, vasculitis, seropositive and seronegative arthritis.
- Patients having history of treatment with systemic agents, having active infection, pregnant and lactating women and patients having severe hematological abnormalities.
- Patients positive for latent infections.
- Patients with weight <25 kg.
Trial locations and contacts
1 site in 1 country.
About this study
To determine the efficacy of oral Tofacitinib in the treatment of moderate to severe alopecia areata, totalis and universalis at tertiary care hospital of Karachi, Pakistan. Efficacy of treatment in patients presenting with alopecia areata will be assessed using SALT Score on follow up at 6,12 and 24 weeks where four categories of treatment response were defined: 0 (re-growth ≤10%), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth >75%). Efficacy will be considered if re-growth ≥ 2.
Read the detailed description
Alopecia areata is a chronic, autoimmune, non-scarring alopecia that involves the destruction of hair follicles (HF) by autoreactive CD8+ T cells. AA can affect any hair-bearing region and can manifest in various patterns ranging from patchy diffuse alopecia to progression to more severe forms such as alopecia totalis (AT) or alopecia universalis (AU). As a common type of alopecia in human, the estimated prevalence of AA is approximately between 0.1% and 0.2%, second only to male and female pattern alopecia. Although it is not life threatening but the psychosocial impact of the disease is a concern. The treatment of advanced forms of alopecia areata (AA) is more challenging than the milder forms and patients with advanced AA often require systemic therapy in order to regrow hair.
Current treatments include steroids (intralesional, topical, and systemic), topical immunotherapy (diphenylcyclopropenone [DPCP], squaric acid dibutylester [SADBE]), topical immunosuppressants (tacrolimus, pimecrolimus), topical minoxidil, and topical prostaglandin analogs (bimatoprost, latanoprost).
Significant breakthroughs in understanding of intracellular cytokine signaling pathways have promoted a dawn of new promising therapeutic agents, known as Janus kinase inhibitors (JAKs), which block signaling of certain cytokines by inhibiting ATP binding within the phosphorylation sites of cytokine receptor homo- or heterodimers, thereby interrupting the JAK/signal transducer and activator of transcription (STAT) pathway and subsequently production of pro-inflammatory cytokines and other mediators associated with AA.
Despite the rapid development of novel JAK inhibitors, including baricitinib and ritlecitinib, tofacitinib remains an effective and the longest-used JAK inhibitor for AA. Tofacitinib primarily targets JAK 1/3 and reduces the immune response and resultant inflammation, emerging as an alternative for the treatment of refractory cases of AA.
In 2014, the first reported case using a JAK1/3 inhibitor, tofacitinib citrate, for the treatment of AU was described in a patient with concomitant plaque psoriasis who achieved full regrowth of hair within 8 months. Since then, the scientific understanding of AA has continued to progress, highlighting the key role that cytotoxic T lymphocytes play in AA and the potential of JAK inhibition. Due to the lack of data regarding efficacy and safety of this drug in alopecia areata we therefore aim to provide a comprehensive literature, evaluate the effectiveness, outcome and role of Tofacitinib in the treatment of AA.
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- Being tested
- Tofacitinib
- Keywords
- Tofacitinib, Alopecia areata, Janus kinase inhibitor, JAK 1/3 inhibitor
- Medical subject headings
- Alopecia Areata, Alopecia universalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
Oral tofacitinib 5mg twice daily for treatment of alopecia areata, totalis and universalis.
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib | Experimental | tofacitinib 5mg twice daily for 6 months Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alopecia
To analyze the efficacy of oral Tofacitinib in moderate to severe alopecia areata, totalis and universalis at Tertiary Care Hospital, Karachi. The effect of treatment will be evaluated using photographs of the patient before and after the trial and clinical evaluation of patients. The clinical response for efficacy will be evaluated at 0, 6,12 and 24 weeks of therapy. Patient presenting with alopecia areata will be assessed for degree of improvement using SALT score on follow up after 3 months as follows: 0 (re-growth ≤10), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth >75%). Efficacy will be considered if re-growth ≥3.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jul 2023
- Primary completion6 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study includes patients with moderate to severe Alopecia Areata, totalis and universalis. The efficacy of JAK 1/3 inhibitor, Tofacitinib will be assessed by using SALT score (Severity of Alopecia Tool) at Baseline, 06 weeks, 12 weeks and 24 weeks. Oral Tofacitinib given at a dose of 5 mg twice daily after relevant investigations. The data will be analyzed in SPSS version 23.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Misbah Zari Qadir, Jinnah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278402
- Sponsor's protocol ID
- JinnahH
- Status last verified
- Feb 2024
- First submitted
- 28 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Literature review, statistical analysis of efficacy of tofacitinib in the treatment of alopecia areata, totalis and universalis.
Publications
Husein-ElAhmed H, Abdulla N, Al-Obaidli A, Ali-Alam M, Steinhoff M. Real-world experience and long-term evaluation of tofacitinib in refractory alopecia areata: A prospective, open-label, single-center study in Asian Arab population. Dermatol Ther. 2022 Dec;35(12):e15871. doi: 10.1111/dth.15871. Epub 2022 Dec 1.
PubMed 36177791Sardana K, Bathula S, Khurana A. Which is the Ideal JAK Inhibitor for Alopecia Areata - Baricitinib, Tofacitinib, Ritlecitinib or Ifidancitinib - Revisiting the Immunomechanisms of the JAK Pathway. Indian Dermatol Online J. 2023 Jun 28;14(4):465-474. doi: 10.4103/idoj.idoj_452_22. eCollection 2023 Jul-Aug.
PubMed 37521227Dillon KL. A Comprehensive Literature Review of JAK Inhibitors in Treatment of Alopecia Areata. Clin Cosmet Investig Dermatol. 2021 Jun 25;14:691-714. doi: 10.2147/CCID.S309215. eCollection 2021.
PubMed 34211288Pratt 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 28300084Donovan J. The Evolving Story of JAK Inhibitors for Treating Alopecia Areata: A Review of Current Progress and Future Directions. Skin Therapy Lett. 2023 May;28(3):1-7.
PubMed 37339501Gupta AK, Carviel JL, Foley KA, Shear NH, Piraccini BM, Piguet V, Tosti A. Monotherapy for Alopecia Areata: A Systematic Review and Network Meta-Analysis. Skin Appendage Disord. 2019 Nov;5(6):331-337. doi: 10.1159/000501940. Epub 2019 Aug 29.
PubMed 31799258Huang J, Deng S, Li J, Tang Y, Liu F, Liu Y, Rao S, Shi W. Drug Survival and Long-term Outcome of Tofacitinib in Patients with Alopecia Areata: A Retrospective Study. Acta Derm Venereol. 2023 Nov 13;103:adv13475. doi: 10.2340/actadv.v103.13475.
PubMed 37955531Damsky W, King BA. JAK inhibitors in dermatology: The promise of a new drug class. J Am Acad Dermatol. 2017 Apr;76(4):736-744. doi: 10.1016/j.jaad.2016.12.005. Epub 2017 Jan 28.
PubMed 28139263Craiglow BG, King BA. Killing two birds with one stone: oral tofacitinib reverses alopecia universalis in a patient with plaque psoriasis. J Invest Dermatol. 2014 Dec;134(12):2988-2990. doi: 10.1038/jid.2014.260. Epub 2014 Jun 18. No abstract available.
PubMed 24940651Liu LY, King BA. Tofacitinib for the Treatment of Severe Alopecia Areata in Adults and Adolescents. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S18-S20. doi: 10.1016/j.jisp.2017.10.003.
PubMed 29273099
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi.
- ClinicalTrials.gov ID
- NCT06278402
- Acronym / sponsor ID
- JinnahH
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- Keywords
- Tofacitinib, Alopecia areata, Janus kinase inhibitor, JAK 1/3 inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jinnah HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 6 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 26 Feb 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.
To determine the efficacy of oral Tofacitinib in the treatment of moderate to severe alopecia areata, totalis and universalis at tertiary care hospital of Karachi, Pakistan. Efficacy of treatment in patients presenting with alopecia areata will be assessed using SALT Score on follow up at 6,12 and 24 weeks where four categories of treatment response were defined: 0 (re-growth ≤10%), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth >75%). Efficacy will be considered if re-growth ≥ 2.
Detailed description
Alopecia areata is a chronic, autoimmune, non-scarring alopecia that involves the destruction of hair follicles (HF) by autoreactive CD8+ T cells. AA can affect any hair-bearing region and can manifest in various patterns ranging from patchy diffuse alopecia to progression to more severe forms such as alopecia totalis (AT) or alopecia universalis (AU). As a common type of alopecia in human, the estimated prevalence of AA is approximately between 0.1% and 0.2%, second only to male and female pattern alopecia. Although it is not life threatening but the psychosocial impact of the disease is a concern. The treatment of advanced forms of alopecia areata (AA) is more challenging than the milder forms and patients with advanced AA often require systemic therapy in order to regrow hair.
Current treatments include steroids (intralesional, topical, and systemic), topical immunotherapy (diphenylcyclopropenone [DPCP], squaric acid dibutylester [SADBE]), topical immunosuppressants (tacrolimus, pimecrolimus), topical minoxidil, and topical prostaglandin analogs (bimatoprost, latanoprost).
Significant breakthroughs in understanding of intracellular cytokine signaling pathways have promoted a dawn of new promising therapeutic agents, known as Janus kinase inhibitors (JAKs), which block signaling of certain cytokines by inhibiting ATP binding within the phosphorylation sites of cytokine receptor homo- or heterodimers, thereby interrupting the JAK/signal transducer and activator of transcription (STAT) pathway and subsequently production of pro-inflammatory cytokines and other mediators associated with AA.
Despite the rapid development of novel JAK inhibitors, including baricitinib and ritlecitinib, tofacitinib remains an effective and the longest-used JAK inhibitor for AA. Tofacitinib primarily targets JAK 1/3 and reduces the immune response and resultant inflammation, emerging as an alternative for the treatment of refractory cases of AA.
In 2014, the first reported case using a JAK1/3 inhibitor, tofacitinib citrate, for the treatment of AU was described in a patient with concomitant plaque psoriasis who achieved full regrowth of hair within 8 months. Since then, the scientific understanding of AA has continued to progress, highlighting the key role that cytotoxic T lymphocytes play in AA and the potential of JAK inhibition. Due to the lack of data regarding efficacy and safety of this drug in alopecia areata we therefore aim to provide a comprehensive literature, evaluate the effectiveness, outcome and role of Tofacitinib in the treatment of AA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study includes patients with moderate to severe Alopecia Areata, totalis and universalis. The efficacy of JAK 1/3 inhibitor, Tofacitinib will be assessed by using SALT score (Severity of Alopecia Tool) at Baseline, 06 weeks, 12 weeks and 24 weeks. Oral Tofacitinib given at a dose of 5 mg twice daily after relevant investigations. The data will be analyzed in SPSS version 23.
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib | Experimental | Drug: Tofacitinibtofacitinib 5mg twice daily for 6 months |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients presenting with Alopecia areata as per operational definition will be included in the study.
- Either gender.
- Age 15 - 60 years.
Key exclusion criteria (4 listed)
- Patient with history of connective tissue disorders, vasculitis, seropositive and seronegative arthritis.
- Patients having history of treatment with systemic agents, having active infection, pregnant and lactating women and patients having severe hematological abnormalities.
- Patients positive for latent infections.
- Patients with weight <25 kg.
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 |
|---|---|---|
| TofacitinibOral tofacitinib 5mg twice daily for treatment of alopecia areata, totalis and universalis. | Drug | Tofacitinib |
Primary outcome
Alopecia
Time frame: 6 months
To analyze the efficacy of oral Tofacitinib in moderate to severe alopecia areata, totalis and universalis at Tertiary Care Hospital, Karachi. The effect of treatment will be evaluated using photographs of the patient before and after the trial and clinical evaluation of patients. The clinical response for efficacy will be evaluated at 0, 6,12 and 24 weeks of therapy. Patient presenting with alopecia areata will be assessed for degree of improvement using SALT score on follow up after 3 months as follows: 0 (re-growth ≤10), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth >75%). Efficacy will be considered if re-growth ≥3.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Results publication: PubMed 36177791Husein-ElAhmed H, Abdulla N, Al-Obaidli A, Ali-Alam M, Steinhoff M. Real-world experience and long-term evaluation of tofacitinib in refractory alopecia areata: A prospective, open-label, single-center study in Asian Arab population. Dermatol Ther. 2022 Dec;35(12):e15871. doi: 10.1111/dth.15871. Epub 2022 Dec 1.
- Results publication: PubMed 37521227Sardana K, Bathula S, Khurana A. Which is the Ideal JAK Inhibitor for Alopecia Areata - Baricitinib, Tofacitinib, Ritlecitinib or Ifidancitinib - Revisiting the Immunomechanisms of the JAK Pathway. Indian Dermatol Online J. 2023 Jun 28;14(4):465-474. doi: 10.4103/idoj.idoj_452_22. eCollection 2023 Jul-Aug.
- Results publication: PubMed 34211288Dillon KL. A Comprehensive Literature Review of JAK Inhibitors in Treatment of Alopecia Areata. Clin Cosmet Investig Dermatol. 2021 Jun 25;14:691-714. doi: 10.2147/CCID.S309215. eCollection 2021.
- Results publication: 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.
- Results publication: PubMed 37339501Donovan J. The Evolving Story of JAK Inhibitors for Treating Alopecia Areata: A Review of Current Progress and Future Directions. Skin Therapy Lett. 2023 May;28(3):1-7.
- Results publication: PubMed 31799258Gupta AK, Carviel JL, Foley KA, Shear NH, Piraccini BM, Piguet V, Tosti A. Monotherapy for Alopecia Areata: A Systematic Review and Network Meta-Analysis. Skin Appendage Disord. 2019 Nov;5(6):331-337. doi: 10.1159/000501940. Epub 2019 Aug 29.
- Results publication: PubMed 37955531Huang J, Deng S, Li J, Tang Y, Liu F, Liu Y, Rao S, Shi W. Drug Survival and Long-term Outcome of Tofacitinib in Patients with Alopecia Areata: A Retrospective Study. Acta Derm Venereol. 2023 Nov 13;103:adv13475. doi: 10.2340/actadv.v103.13475.
- Results publication: PubMed 28139263Damsky W, King BA. JAK inhibitors in dermatology: The promise of a new drug class. J Am Acad Dermatol. 2017 Apr;76(4):736-744. doi: 10.1016/j.jaad.2016.12.005. Epub 2017 Jan 28.
- Results publication: PubMed 24940651Craiglow BG, King BA. Killing two birds with one stone: oral tofacitinib reverses alopecia universalis in a patient with plaque psoriasis. J Invest Dermatol. 2014 Dec;134(12):2988-2990. doi: 10.1038/jid.2014.260. Epub 2014 Jun 18. No abstract available.
- Results publication: PubMed 29273099Liu LY, King BA. Tofacitinib for the Treatment of Severe Alopecia Areata in Adults and Adolescents. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S18-S20. doi: 10.1016/j.jisp.2017.10.003.
- Individual participant dataSharing planned: Yes. Literature review, statistical analysis of efficacy of tofacitinib in the treatment of alopecia areata, totalis and universalis.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tofacitinib in people with Alopecia Areata and Alopecia Totalis, run by Jinnah Hospital at 1 site in Pakistan.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 26 Feb 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 Pakistan. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alopecia (time frame: 6 months). 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 NCT06278402, which also lists 10 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 26 Feb 2024.