Trial · NCT02299297

Study To Evaluate The Efficacy Of Tofacitinib In Moderate To Severe Alopecia Areata, Totalis And Universalis

NCT02299297, Phase 2, Completed, Columbia University; results first posted 2019-05-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study To Evaluate The Efficacy Of Tofacitinib In Moderate To Severe Alopecia Areata, Totalis And Universalis. Trials, record NCT02299297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02299297

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study To Evaluate The Efficacy Of Tofacitinib In Moderate To Severe Alopecia Areata, Totalis And Universalis
NCT number: NCT02299297
Status: Completed
Phases: Phase 2
Enrollment: 12 participants, actual
Lead sponsor: Columbia University
Conditions: Alopecia Areata
Interventions: Tofacitinib
First posted: 2014-11-24
Last updated: 2019-05-07
Results first posted: 2019-05-07

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total Number of Responders	Baseline up to between 24 and 72 weeks	This is defined as 50% or greater hair re-growth from baseline as assessed by the Severity of ALopecia Tool (SALT) score after up to 24 weeks/6 months to 72 weeks/18 months of treatment. This is a relatively strict definition for defining responders and non-responders and was chosen to minimize the potential for spontaneous remission, in which fewer than 10% are expected to achieve this magnitude of hair regrowth spontaneously.
Secondary	Total Number of Responders Maintaining Response During the Post-Treatment Follow Up Period	Week 24	To assess the durability of responses, patients who achieve 50% regrowth from baseline during the first 6 to 18 months, will continue to be followed for an additional 6 months post-treatment or until it is determined that relapse has occurred. Durability of response was measured by comparing SALT scores from baseline to 24 weeks after treatment.
Secondary	Total Number of Responders With Change in PHYSICIAN Global Assessment Score	Up to 24 weeks	A physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe). Responders are defined by participants who exhibited regrowth.
Secondary	Percentage of Regrowth	Baseline up to between 24 and 72 weeks	Percentage of regrowth was measured by comparing the SALT score at the beginning and end of treatment.
Secondary	Dermatology Life Quality Index (DLQI) Score	Up to 24 weeks	The first dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire used to evaluate patient's quality of life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Total Number of Responders	Baseline up to between 24 and 72 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Total Number of Responders Maintaining Response During the Post-Treatment Follow Up Period	Week 24	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Total Number of Responders With Change in PHYSICIAN Global Assessment Score	Up to 24 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Regrowth	Baseline up to between 24 and 72 weeks	percentage of regrowth	MEAN
SECONDARY	Dermatology Life Quality Index (DLQI) Score	Up to 24 weeks	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Total Number of Responders	Tofacitinib		8		Participants
Total Number of Responders Maintaining Response During the Post-Treatment Follow Up Period	Tofacitinib		3		Participants
Total Number of Responders With Change in PHYSICIAN Global Assessment Score	Tofacitinib		8		Participants
Percentage of Regrowth	Tofacitinib		56.8	Full Range 12.1 to 100	percentage of regrowth
Dermatology Life Quality Index (DLQI) Score	Tofacitinib	Baseline	6.5	Standard Deviation 5.0	score on a scale
Dermatology Life Quality Index (DLQI) Score	Tofacitinib	3 months	5.2	Standard Deviation 6.7	score on a scale
Dermatology Life Quality Index (DLQI) Score	Tofacitinib	6 months	6	Standard Deviation 6.9	score on a scale

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tofacitinib	12
Overall Study	COMPLETED	Tofacitinib	11
Overall Study	NOT COMPLETED	Tofacitinib	1

Source ClinicalTrials.gov

Adverse events17

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Upper respiratory infection	Infections and infestations	Tofacitinib	11	12	11
other	increased bowel movement frequency	Renal and urinary disorders	Tofacitinib	4	12	4
other	Blood on urinalysis	Blood and lymphatic system disorders	Tofacitinib	4	12	4
other	Loose stools	Metabolism and nutrition disorders	Tofacitinib	3	12	3
other	Mild acne	General disorders	Tofacitinib	3	12	3
other	Weight gain	Metabolism and nutrition disorders	Tofacitinib	2	12	2
other	Asymptomatic bacteriuria	Infections and infestations	Tofacitinib	2	12	2
other	Hypertensive urgency	Vascular disorders	Tofacitinib	1	12	1
other	Bloating	General disorders	Tofacitinib	1	12	1
other	Constipation	Metabolism and nutrition disorders	Tofacitinib	1	12	1

1 to 10 of 17Source ClinicalTrials.gov

See all 17 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tofacitinib	0	12
Total, other adverse events	Tofacitinib	12	12
Total, serious adverse events	Tofacitinib	0	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29452121	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02299297

GET https://conductscience.org/api/trials/v1/NCT02299297/registered

API reference For AI assistants