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NCT03800979

Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata

Completed Phase 4 Results posted Last updated 31 March 2022
What this trial tests

Phase 4 trial testing Tofacitinib in Alopecia Areata in 19 participants. Completed in 30 January 2021.

Timeline
12 January 2019
Primary endpoint
30 January 2021
30 January 2021

Quick facts

Lead sponsorInstitute of Dermatology, Thailand
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment19
Start date12 January 2019
Primary completion30 January 2021
Estimated completion30 January 2021
Sites1 location across Thailand

Drugs / interventions tested

Conditions studied

Sponsor

Institute of Dermatology, Thailand

Who can join

Adults 18 to 60, any sex, with Alopecia Areata. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Responders vs Non-Responders Using SALT Score Primary · 48 weeks

The Severity of Alopecia Tool (SALT) is a measurement procedure used by dermatologists to determine the percentage of scalp hair loss. The SALT system divides the scalp into 4 areas: Top has 4 sections of 10% total are 40%, back has 4 sections of 6% total are 24% and the 2 sides, left and right, each has 2 sections of 4% and 2 sections of 5% total of 18% and 36% combined. In the beginning, the area of hair loss would be measured by checking each area for hair loss and determining the bald spots combined per SALT scale then keeping the record as SALT baseline (SALT). The total SALT score is mea

GroupValue95% CI
Tofacitinib9
Tofacitinib10
Side Effects From Tofacitinib Secondary · 48 weeks

Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48.

Dyslipidemia
GroupValue95% CI
Tofacitinib9
Upper respiratory tract infection
GroupValue95% CI
Tofacitinib6
Tuberculosis
GroupValue95% CI
Tofacitinib1
Myalgia
GroupValue95% CI
Tofacitinib1
Acne
GroupValue95% CI
Tofacitinib2
Weight gain
GroupValue95% CI
Tofacitinib1
Constipation
GroupValue95% CI
Tofacitinib1

Adverse events — posted to ClinicalTrials.gov

Time frame: Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tofacitinib
Serious: 1/19 (5%)
Deaths: 0/19

Serious adverse events (1 terms)

ReactionSystemTofacitinib
Intestinal tuberculosisGastrointestinal disorders
Other adverse events (6 terms — click to expand)

ReactionSystemTofacitinib
DyslipidemiaMetabolism and nutrition disorders
Upper respiratory tract infectionInfections and infestations
AcneSkin and subcutaneous tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
Weight gainMetabolism and nutrition disorders
ConstipationGastrointestinal disorders

Most-reported serious reactions: Intestinal tuberculosis.

Data from ClinicalTrials.gov NCT03800979 adverse events section.

Sponsor's own description

The objective of this study is to assess the safety and efficacy of Tofacitinib in treating patients with extensive and recalcitrant Alopecia Areata (AA), along with to evaluate the economic impact of the patients that may be from changing in their quality of life. There are patients with severe AA who may have little or no improvement from the treatment by diphenylcyclopropenone (DPCP) or topical steroid with minoxidil but instead having positive response from the treatment with Janus kinase(JAK) inhibitor such as Tofacitinib or Ruxolitinib. For the best of my knowledge, there was no previous study in using Tofacitinib to treat severe AA before in Thailand.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Janus kinase-targeting therapies in rheumatology: a mechanisms-based approach.
    Tanaka Y, Luo Y, O'Shea JJ, Nakayamada S. · · 2022 · cited 329× · PMID 34987201 · DOI 10.1038/s41584-021-00726-8
  2. Emerging Topical and Systemic JAK Inhibitors in Dermatology.
    Solimani F, Meier K, Ghoreschi K. · · 2019 · cited 199× · PMID 31849996 · DOI 10.3389/fimmu.2019.02847
  3. JAK/STAT pathway: Extracellular signals, diseases, immunity, and therapeutic regimens.
    Hu Q, Bian Q, Rong D, Wang L, et al · · 2023 · cited 190× · PMID 36911202 · DOI 10.3389/fbioe.2023.1110765
  4. STAT proteins: a kaleidoscope of canonical and non-canonical functions in immunity and cancer.
    Awasthi N, Liongue C, Ward AC. · · 2021 · cited 97× · PMID 34809691 · DOI 10.1186/s13045-021-01214-y
  5. A Comprehensive Literature Review of JAK Inhibitors in Treatment of Alopecia Areata.
    Dillon KL. · · 2021 · cited 48× · PMID 34211288 · DOI 10.2147/ccid.s309215
  6. Alopecia Areata: Pathogenesis, Diagnosis, and Therapies.
    Ma T, Zhang T, Miao F, Liu J, et al · · 2025 · cited 13× · PMID 40260013 · DOI 10.1002/mco2.70182
  7. The assessment of efficient representation of drug features using deep learning for drug repositioning.
    Moridi M, Ghadirinia M, Sharifi-Zarchi A, Zare-Mirakabad F. · · 2019 · cited 8× · PMID 31726977 · DOI 10.1186/s12859-019-3165-y
  8. Novel Janus Kinase Inhibitors in the Treatment of Dermatologic Conditions.
    Ryguła I, Pikiewicz W, Kaminiów K. · · 2023 · cited 6× · PMID 38138551 · DOI 10.3390/molecules28248064

Verify or expand the search:

Other trials of Tofacitinib

Trials testing the same drug.

Other recruiting trials for Alopecia Areata

Currently open trials in the same condition.

Other Institute of Dermatology, Thailand trials

Trials by the same sponsor.

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