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NCT06259669: OPERA-1
Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population
trial testing Ruxolitinib Cream in Pregnancy Related in 958 participants. Currently enrolling.
1 August 2032
Quick facts
| Lead sponsor | Incyte Corporation |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 958 |
| Start date | 13 September 2023 |
| Primary completion | 1 August 2032 |
| Estimated completion | 1 August 2033 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ruxolitinib Cream — full drug profile →
Conditions studied
- Pregnancy Related — all drugs for Pregnancy Related →
- Atopic Dermatitis — all drugs for Atopic Dermatitis →
Sponsor
Incyte Corporation — full company profile →
Who can join
Adults 15 to 50, female only, with Pregnancy Related or Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during pregnancy with infants of women not exposed to ruxolitinib cream during pregnancy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06259669
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ruxolitinib Cream
Trials testing the same drug.
- NCT06804811 — A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vit · Phase 3 · recruiting
- NCT07049575 — Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativ · Phase 1 · recruiting
- NCT06959225 — Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1) · Phase 3 · recruiting
- NCT06958211 — Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2) · Phase 3 · recruiting
- NCT06548360 — A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo · Phase 3 · recruiting
Other recruiting trials for Pregnancy Related
Currently open trials in the same condition.
- NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting
- NCT07517549 — Sexual Health Education During Pregnancy · NA · recruiting
- NCT07293559 — Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States · recruiting
- NCT07518550 — Maternal and Fetal Electrocardiograms Separation Algorithm · NA · recruiting
- NCT06965530 — Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy · NA · recruiting
Other Incyte Corporation trials
Trials by the same sponsor.
- NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di · Phase 2 · recruiting
- NCT07441694 — Study of INCA036978 in Participants With Myeloproliferative Neoplasms · Phase 1 · recruiting
- NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
- NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not recruiting
- NCT07284849 — A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 i · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06259669 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
- Last refreshed: 11 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06259669.
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