"Randomized Controlled Trial Testing the Efficacy of Corticosteroid Therapy Versus Placebo in Fibrotic Hypersensitivity Pneumonitis"

NCT07210008 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: APHP2409082025-521591-64-00
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypersensitivity Pneumonitis (HP) is an immune-mediated disease that manifests as interstitial lung disease after exposure to an inhaled antigen, often unidentified. HP can be classified as non-fibrotic or fibrotic HP. Fibrotic HP is associated with impaired quality of life (QoL) and reduced survival. The value and decline of forced vital capacity (FVC) are predictive factors of mortality in fibrotic HP. In most expert centres worldwide, corticosteroids are chosen as the first-line drug to treat fibrotic HP in clinical practice. However, this strategy has not been validated in a randomized controlled trial and it remains controversial, Moreover, corticosteroids are responsible for potentially serious adverse events. The hypothesis is that prednisolone, as a first-line treatment in fibrotic hypersensitivity pneumonitis (HP), slows down FVC decline compared to placebo. The main objective is to assess the efficacy of first-line treatment with prednisolone against placebo, on the 6-month change in FVC in percent of predicted value (% pred).The primary endpoint will be the absolute change in FVC (% pred) from baseline (inclusion visit,M0) to 6 months (M6) will be compared between the placebo arm and the prednisolone arm.

Conditions

Hypersensitivity Pneumonitis

Outcome Measures

Primary Outcomes (1)

• Absolute change in FVC (% pred)

  Absolute change in FVC (% pred) from baseline (inclusion visit, M0) to 6 months (M6) will be compared between the placebo arm and the prednisolone arm.

  at month 6

Secondary Outcomes (18)

• Absolute change in FVC (% pred) according to the presence of a causal antigen at Month 6

  at Month 6

• The change in FVC (% pred) at 12 months (M12)

  At month 12

• The change in FVC (mL) at 12 months (M12)

  At month 12

• The changes in DLco (mmol/min/kPa) at Month 6

  At Month 6

• The changes in DLco (% pred) at Month 6

  At Month 6

Study Arms (2)

Prednisolone (oral)

EXPERIMENTAL

Prednisolone (oral) will be administered and tapered over 6 months, according to the schedule detailed in the protocol(Cumulative dose: 2430mg/ 6months). Active Comparator: prednisolone. Oral prednisolone will be administered and tapered over 6 months, according to the following schedule: 0.5 mg/kg/day (not exceeding 40mg/day) x 4 weeks, 0.25 mg/kg/day (not exceeding 20mg/day) x 4 weeks, 15 mg/day x 4 weeks, 10 mg/days x 4 weeks, 5 mg/day x 10 weeks

Drug: Prednisolone

Placebo

PLACEBO COMPARATOR

Dispersible placebo administered and tapered over 6 months according to the schedule detailed in the protocol

Drug: Placebo

Interventions

Prednisolone DRUG

Active Comparator: prednisolone. Oral prednisolone will be administered and tapered over 6 months, according to the following schedule\*: 0.5 mg/kg/day (not exceeding 40mg/day) x 4 weeks, 0.25 mg/kg/day (not exceeding 20mg/day) x 4 weeks, 15 mg/day x 4 weeks, 10 mg/days x 4 weeks, 5 mg/day x 10 weeks

Prednisolone (oral)

Placebo DRUG

Dispersible placebo administered and tapered over 6 months according to the schedule detailed in the protocol

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged above 18 years and under 90 years old
• Diagnosis of fibrotic HP ("definite" or "high confidence") after MDD according to the criteria proposed by guidelines \[5\]
• Fibrosis extent ≥ 10% on chest HRCT
• Mild to moderate functional impairment defined by FVC ≥ 50% pred and DLco ≥ 30% pred
• Written informed consent for participation in study
• Patient affiliated to a social security scheme or CMU beneficiary
• Effective contraception for men and woman of childbearing age.

You may not qualify if:

• Uncertain diagnosis of fibrotic HP ("low confidence" or "unlikely") after MDD according to the criteria proposed by guidelines \[5\].
• Severe functional impairment defined by FVC \< 50% pred and DLco \< 30% pred.
• Patient previously treated or currently being treated for fibrotic HP (with corticosteroids, any immunosuppressive agent, or anti- fibrotic therapies).
• Person under guardianship/ curatorship (sous tutelle/curatelle)
• Contraindication to corticosteroid therapy (hypersensitivity to the active substances or to one of the excipients, severe infections, psychotic states not controlled by treatment, live vaccines, uncontrolled diabetes mellitus and uncontrolled arterial hypertension.) or to auxiliary medicinal products
• Patient deprived of liberty under judicial or administrative decision
• Patient participating in another clinical trial with an investigational medicinal product. The patient may participate in another clinical trial after the 6 months of treatment in this study
• Pregnancy or breastfeeding woman
• Patient receiving AME (state medical assistance)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lucile SESE

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Lucile SESE

CONTACT

06 67 72 91 03; lucile.sese@aphp.fr

Hilario NUNES

CONTACT

01 48 95 51 21; hilario.nunes@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: October 7, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-09