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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002365-18 | EudraCT Number |
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The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, severe alopecia areata. Patients from European sites who previously completed a qualifying CTP-543 clinical trial may participate in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTP-543 | Experimental | Patients who previously completed a qualifying CTP-543 clinical trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP-543 | Drug | Twice daily dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety | 108 weeks | |
| Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108 | SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). This outcome measures the relative Change from Pre-zero Baseline in Total SALT Scores. Relative change from baseline was defined as 100*(post-baseline value - baseline)/baseline. | 108 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Dermatologie CHRU de Brest - Hopital Morvan | Brest | Finistere | 29609 | France | ||
| Service de Dermatologie Centre Hospitalier Universitaire de Nice - Hopital Archet 2 |
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| ID | Title | Description |
|---|---|---|
| FG000 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, twice a day |
| FG001 | CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, twice a day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 13, 2023 | Jul 17, 2025 |
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| Nice |
| Provence-Alpes-Côte d'Azur Region |
| 06202 |
| France |
| CHU de Bordeaux, Hopital Saint-Andre | Bordeaux | 33000 | France |
| Hopital Saint-Louis - GH De La Rochelle-Re-Aunis | La Rochelle | 17019 | France |
| Hôpital La Timone-Dermatologie | Marseille | 13385 | France |
| Hopital de l'Hotel Dieu - CHU de Nantes | Nantes | 22093 | France |
| Hôpital Saint Louis, Centre de Santé Sabouraud | Paris | 75010 | France |
| Centre Hospitalier Universitaire de Toulouse - Hopital Larrey | Toulouse | 31059 | France |
| Universitätsklinikum Tübingen Universitäts-Hautklinik | Tübingen | Baden-Wüttermberg | 72076 | Germany |
| Universitätsklinikum Erlangen, Hautklinik | Erlangen | Bavaria | 91054 | Germany |
| Klinikum Rechts der Isar, Technische Universität München, Hautklinik | München | Bavaria | 80802 | Germany |
| Klinik für Dermatologie, Venerologie und Allergologie | Frankfurt am Main | Hesse | 60590 | Germany |
| Fachklinik Bad Bentheim | Bad Bentheim | Lower Saxony | 48455 | Germany |
| Klinik für Dermatologie und Venerologie, Zentrale Studienkoordination für innovative Dermatologie (ZiD) | Münster | North Rhine-Westphalia | 48149 | Germany |
| Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-, Nemikortani es Onkodermatologiai Klinika | Pécs | Baranya | 7632 | Hungary |
| SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika | Szeged | Csongrad-Csanad County | 6720 | Hungary |
| Semmelweis Egyetem AOK, Bor-, Nemikortani es Boronkologiai Klinika | Budapest | Pest County | 1085 | Hungary |
| Twoja Przychodnia Centrum Medyczne Nowa Sol | Nowa Sól | Lubusz Voivodeship | 67-100 | Poland |
| ETG Siedlce | Siedlce | Masovian Voivodeship | 08-110 | Poland |
| ETG Skierniewice | Skierniewice | Masovian Voivodeship | 96-100 | Poland |
| RCMed Oddzial w Sochaczewie | Sochaczew | Masovian Voivodeship | 96-500 | Poland |
| OT.CO Clinic Klinika Osipowicz & Turkowski sp. z o.o | Warsaw | Masovian Voivodeship | 00-716 | Poland |
| Carpe Diem Centrum Medycyny Estetycznej | Warsaw | Masovian Voivodeship | 02-661 | Poland |
| ETG Warszawa | Warsaw | Masovian Voivodeship | 02-793 | Poland |
| NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL | Bialystok | 15-453 | Poland |
| Vita Longa Sp.Zo.O | Katowice | 40-748 | Poland |
| Specjalistyczny Gabinet Dermatologiczny s.c. | Krakow | 30-002 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71-500 | Poland |
| My Clinic | Warsaw | 00-144 | Poland |
| Royalderm Agnieszka Nawrocka | Warsaw | 02-962 | Poland |
| WroMedica I. Bielicka, A. Strazalkowska s.c. | Wroclaw | 51-685 | Poland |
| Hospital Clínic de Barcelona | Barcelona | Barcelona/Cataluña | 08036 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital de La Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, twice a day |
| BG001 | CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, twice a day |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events as a Measure of Safety | All subjects who received at least 1 dose of CTP-543 in this study. Subjects could be counted in both CTP-543 dose groups due to dose changes. | Posted | Count of Participants | Participants | No | 108 weeks |
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| Primary | Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108 | SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). This outcome measures the relative Change from Pre-zero Baseline in Total SALT Scores. Relative change from baseline was defined as 100*(post-baseline value - baseline)/baseline. | Subjects received ≥1 dose of CTP-543 and ≥1 post-baseline SALT score. The 12 mg BID dose was removed per amended protocol; those on it were reduced to 8 mg BID and are shown in the (12→8 mg BID) group. Max 12 mg BID exposure was 81 weeks; by week 108, no subjects remained on it. Participant Flow reflects planned groups based on prior dose (active) or randomization (placebo). Analysis is based on initial treatment, then first new dose if changed. | Posted | Mean | Standard Deviation | Percentage change | 108 weeks |
|
108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, twice a day | 0 | 367 | 16 | 367 | 176 | 367 |
| EG001 | CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, twice a day | 0 | 273 | 5 | 273 | 127 | 273 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bartholin's abscess | Infections and infestations | Systematic Assessment |
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| Hepatitis E | Infections and infestations | Systematic Assessment |
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| Infectious mononucleosis | Infections and infestations | Systematic Assessment |
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| Tonsillitis | Infections and infestations | Systematic Assessment |
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| Wound infection | Infections and infestations | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Synovial cyst | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | Systematic Assessment |
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| Gastric cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Bartholin's cyst | Reproductive system and breast disorders | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Tricuspid valve incompetence | Cardiac disorders | Systematic Assessment |
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| Type 1 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
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| Intracranial hypotension | Nervous system disorders | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Weight increased | Investigations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Asymptomatic COVID-19 | Infections and infestations | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Folliculitis | Infections and infestations | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, Regulatory Affairs | Sun Pharmaceutical Industries Limited | 9122 66455645 | Clinical.Trial@sunpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 14, 2024 | Jul 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| CTP-543 12 mg BID to CTP-543 8 mg BID |
Participants received CTP-543 12 mg tablets orally, twice daily as the first actual treatment, then 8 mg orally, twice daily as the first dose change. |
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