ORPHA:163525
Subacute cutaneous lupus erythematosus
Publications
1,647
86.7th percentile
Trials
9
Interventional, condition-specific
Researchers
925
Distinct authors in sample
Gene link
—
Readiness
3/6
Stages with a signal
Clinical definition (Orphanet)
A form of cutaneous lupus erythematosus (CLE) that can present either as a non-scarring, annular photo-distributed dermatosis or psoriasiform plaques. This disorder is associated with anti-Ro/SSA antibodies and can be drug-induced.
How rare: 1-9 / 1 000 000 — roughly one to nine people per million. In a city the size of Kolkata, perhaps a few dozen.
Cross-references
Joined from Mondo / Orphanet. MeSH labels may enter searches; UMLS / OMIM / NCIT are stored for reference.
- MONDO:0015573
- UMLS:C0024140
- NCIT:C117111
Research stages
Trial readiness signals
Where this condition sits on an open-data research pipeline — not how close a treatment is, and not medical advice. Empty stages often mean “not in these databases under this Mondo ID,” not “impossible.”
3/6 stages with a signal
An interventional trial matched this condition name on ClinicalTrials.gov — see trials below.
- Gene identifiedNot found
No GenCC disease–gene assertion in this build
- LiteraturePresent
1,647 matched papers (856 in last 10 years) Source
- Phenotype characterisedPresent
19 HPO annotations (e.g. Anti-Ro/SS-A antibody positivity; Annular cutaneous lesion; Vasculitis in the skin) Source
- Animal modelNot found
No Alliance genotype “model of” associations via Monarch for these Mondo IDs
- Orphan designationNot found
No FDA or EMA orphan-drug designation matched this disease via UMLS or preferred name Source
- Interventional trialPresent
9 matched on ClinicalTrials.gov (2 recruiting in sample)
Biology
Genes and phenotypes
Gene–disease validity from GenCC, plus phenotypes and animal models joined from Monarch Initiative via Mondo ID — not a clinical diagnosis aid.
Do we know what causes it?
Not yet — the cause hasn't been pinned down in GenCC.
No strong gene–disease assertion joined for this Orphanet entity.
Phenotypes (Monarch / HPO)
19
Associated phenotypes · MONDO:0015573
- Anti-Ro/SS-A antibody positivity
- Annular cutaneous lesion
- Vasculitis in the skin
- Antinuclear antibody positivity
- Psoriasiform lesion
Showing 5 of 19 — open Monarch for the full list.
Animal models (Monarch / Alliance)
None returned for this Mondo ID. Empty here is not proof that no model organism work exists under another name or gene.
Monarch fetch 2026-07-27
Therapies
Designations, candidates, and chemicals
FDA OOPD and EMA orphan designations, Open Targets clinical candidates, and CTD chemical associations via MyDisease.info. These never change the interventional-trial headline.
Orphan designation (FDA · EMA)
No designation matched this disease via UMLS or preferred name on the FDA OOPD mirror or EMA orphan register. Absence here is not proof that none exists under another wording.
Open Targets candidates
No drugs or clinical candidates returned for this Mondo ID on Open Targets.
CTD chemicals (MyDisease.info)
No CTD chemical associations returned for this Mondo ID.
Literature
Is anyone studying this?
1,647
1,647 papers have been published on this condition. That is a real research literature — still far smaller than common diseases (breast cancer: over 700,000 papers). Median papers in the last 10 years for a rare disease in this dataset (publications denominator n=3967) is 59.
1,647 papers since the earliest indexed year in this search — median last-10-year count for a rare disease in this dataset is 59 (publications denominator n=3967).
856 in the last 10 years · high confidence · 86.7th percentile (publications denominator)
Phrase hits: 1,647 · MeSH hits: 0
Who's working on it?
925
Distinct author names in 200 sampled papers — named people below.
Who's working on it?
People publishing on this condition (sampled Europe PMC records). Affiliation is the most recent found in that sample.
- 01Werth VP6 papers · 2026
Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Dermatology, Corporal Michael J. Crescenz VAMC, Philadelphia, Pennsylvania. Electronic address: werth@pennmedicine.upenn.edu.
Papers in Europe PMC - 02Wang C4 papers · 2025
Department of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, China.
Papers in Europe PMC - 03Hidvégi B3 papers · 2026
Department of Dermatology, Venereology and Dermatooncology, Semmelweis University, Budapest, Hungary.
Papers in Europe PMC - 04Király Z3 papers · 2026
Department of Dermatology, Venereology and Dermatooncology, Semmelweis University, Budapest, Hungary.
Papers in Europe PMC - 05Kleitsch J3 papers · 2025
Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Dermatology, Corporal Michael J. Crescenz VAMC, Philadelphia, Pennsylvania.
Papers in Europe PMC - 06Lu Q3 papers · 2026
Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China qianlu5860@pumcderm.cams.cn.
Papers in Europe PMC - 07Ma S3 papers · 2025
Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang, China.
Papers in Europe PMC - 08Mohta A3 papers · 2023
Departments of Preventive and Social Medicine, Sardar Patel Medical College, Bikaner, Rajasthan, India.
Papers in Europe PMC - 09Motaparthi K3 papers · 2025
Dermatology, University of Florida, Gainesville, USA.
Papers in Europe PMC - 10Wenzel J3 papers · 2026
Department for Dermatology and Allergy, Center for Skin Diseases, University Hospital Bonn, Bonn, Germany.
Papers in Europe PMC
Clinical research
Is a treatment being tested?
9
interventional trials for this specific condition
9 interventional trials matched this specific condition name; 2 currently recruiting in our sample. 39 trials are registered for cutaneous lupus erythematosus, the broader category — shown separately because they may or may not enrol this specific subtype.
Data as of 9 September 2026
9 interventional trials — more than 77.2% of diseases in the trials denominator have none at all (5501 of 7126; this disease is at the 92th percentile).
high confidence · 92th percentile (trials denominator)
Recruiting interventional trials
From the matched ClinicalTrials.gov set
9 interventional trials matched after quoted-phrase search and title/condition post-filter.
- NCT06044337·ENROLLING BY INVITATION·A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Confirmed·Conditions: Subacute Cutaneous Lupus Erythematosus · Chronic Cutaneous Lupus Erythematosus·Matched via name phraseBoth providers judged relevant.
- NCT06875960·RECRUITING·A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132
Uncertain·Conditions: Systemic Lupus Erythematosus (SLE) · Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)·Matched via name phraseAt least one provider returned uncertain or parent-category.
Broader category: cutaneous lupus erythematosus
39
Interventional trials for the parent category, exclusive of NCT IDs already counted above. Eligibility for this subtype is not guaranteed.
Worth raising with a clinician. How we count trials.
Recruiting under the broader category
- NCT06965244·NOT YET RECRUITING·Lenalidomide vs Methotrexate in Difficult-to-treat Cutaneous Lupus Erythematosus
Parent·Conditions: Cutaneous Lupus Erythematosus (CLE)·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07072611·RECRUITING·Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
Parent·Conditions: Cutaneous Lupus Erythematosus·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07355218·RECRUITING·A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Parent·Conditions: Systematic Lupus Erythematosus · Cutaneous Lupus Erythematosus·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT06625671·RECRUITING·A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
Parent·Conditions: Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07455578·RECRUITING·Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease
Parent·Conditions: Autoimmune Diseases · Rheumatoid Arthritis (RA) · Psoriatic Arthritis (PsA) · Psoriasis (PsO)·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07332481·RECRUITING·A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Parent·Conditions: Systemic Lupus Erythematosus (SLE) · Cutaneous Lupus Erythematosus (CLE)·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07306585·NOT YET RECRUITING·The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE
Parent·Conditions: Systemic Lupus Erythematosus (SLE) · Cutaneous Lupus Erythematosus (CLE)·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT06661213·ENROLLING BY INVITATION·Tapinarof for Cutaneous Lupus Erythematosus
Parent·Conditions: Cutaneous Lupus Erythematosus·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07440537·RECRUITING·Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study
Parent·Conditions: Cutaneous Lupus Erythematosus (CLE)·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07408908·NOT YET RECRUITING·Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..
Parent·Conditions: Systemic Lupus Erythematosus · Cutaneous Lupus Erythematosus·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07694336·NOT YET RECRUITING·A Study of Quinacrine in Participants With Cutaneous Lupus Erythematosus
Parent·Conditions: Cutaneous Lupus Erythematosus (CLE)·Matched via name phraseBoth providers judged relevant only to a broader parent category.
- NCT07260877·RECRUITING·A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Parent·Conditions: Cutaneous Lupus Erythematosus (CLE) · Systemic Lupus Erythematosus · SLE · SLE (Systemic Lupus)·Matched via name phraseBoth providers judged relevant only to a broader parent category.
Observational and natural-history studies
1 observational study matches this condition. These do not test a treatment and are not counted in the interventional-trial headline, but they are genuine research: natural-history work often defines the endpoints needed for a future rare-disease trial, and families may be able to enroll.
None of the matched observational studies is currently listed as recruiting.
Other registries (secondary)
Broader net from EU CTIS, ISRCTN, and ICTRP when available — deduped against ClinicalTrials.gov IDs already counted above. Dual-model LLM relevance gates what we keep. These rows are not added to the interventional headline.
raw 10 · after dedupe 9 · already on CT.gov 0 · kept 6 · parent 1 · uncertain 2 · dropped 0 · fetched 2026-07-27
Source notes: ictrp: Error: ICTRP public search unavailable (WHO portal is SPA-only; SOAP needs partnership). Tried: https://apps.who.int/tri
- ctis·2024-516745-39-00·Expired·A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants with Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations.
Confirmed — Both providers judged relevant.
- ctis·2023-503692-24-00·Expired·A Multicenter, Randomized, Double‑blind, Placebo‑controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Antimalarial Therapy
Confirmed — Both providers judged relevant.
- ctis·2023-505634-94-00·Expired·A 2-Part Seamless Part A (Phase 2)/ Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus with or without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
Confirmed — Both providers judged relevant.
- ctis·2023-504863-17-00·Authorised, ongoing·A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST LTE)
Confirmed — Both providers judged relevant.
- ctis·2022-503009-39-00·Cancelled·Multiple Ascending Doses of BMS-986326 in Participants with Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus
Confirmed — Both providers judged relevant.
- ctis·2023-504161-22-00·Expired·A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Confirmed — Both providers judged relevant.
Broader / parent-category hits (1)
- ctis·2025-524855-30-00·Authorised·A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care
Parent category — Both providers judged relevant only to a broader parent category.
Uncertain / not reviewed (2)
- ctis·2024-510871-39-00·Expired·A Phase 2, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants with Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment (WILLOW LTE)
Uncertain — At least one provider returned uncertain or parent-category.
- ctis·2024-510872-18-00·Cancelled·A Phase 2, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging, Parallel and Adaptive Study to Evaluate the Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus and in Cutaneous Lupus Erythematosus (Subacute Cutaneous Lupus Erythematosus and/or Discoid Lupus Erythematosus) Participants Receiving Standard of Care
Uncertain — At least one provider returned uncertain or parent-category.
Where to find support
Condition-specific patient organisations, when Orphanet lists them, are on the disease’s Orphanet page. We also link umbrella groups that support undiagnosed and ultra-rare families.
Orphanet entry for Subacute cutaneous lupus erythematosus — check Associations / patient organisations on that page.
India — NPRD
Last verified 2026-07-26This ORPHAcode is not on our curated NPRD list (direct or Mondo-parent match). That does not decide clinical eligibility; families in India should ask a notified Centre of Excellence about current coverage.
Hand-curated for this project. ORPHAcode mappings are best-effort and may be incomplete or imprecise for umbrella categories. Parent (Mondo) matches mean the policy lists a broader category — confirm eligibility with a Centre of Excellence. Financial entitlements summarised from public policy statements and may change. This is not official government guidance.
How we counted this
Europe PMC query (preferred label + any corrected label + Orphanet and Mondo exact synonyms, stoplisted; unioned with resolved MeSH labels when available). UMLS / OMIM / NCIT cross-references are stored on the overview but are not added to the query string.
"Subacute cutaneous lupus erythematosus"
ClinicalTrials.gov query (quoted phrases + MeSH via query.cond, plus recall-expansion terms when used):
"Subacute cutaneous lupus erythematosus"
Interventional trials matched via: phrase (mesh = registered under a MeSH descriptor no name phrase would catch; recall-expansion = gene / selected parent terms used only for trials).
Study-type breakdown: 9 interventional · 1 observational · 0 expanded access. Only interventional studies enter the trial headline.
Parent-category trials query:
"cutaneous lupus erythematosus"
Query health: ok — strategies attempted: phrase; with hits: phrase
Run this search on ClinicalTrials.gov
Confidence reasoning
- Preferred label is multi-word and distinctive
- No synonyms dropped by stoplist
- No label/synonym collisions with other diseases in this corpus
Ingested 2026-07-26T02:12:08.865Z
