Hypersensitivity PneumonitisPhase 3RUBYNCT07210008
"Randomized Controlled Trial Testing the Efficacy of Corticosteroid Therapy Versus Placebo in Fibrotic Hypersensitivity Pneumonitis"
A Phase 3 study testing Prednisolone in people with Hypersensitivity Pneumonitis, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypersensitivity Pneumonitis
- What is being tested?
- Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Controlled Trial Testing the Efficacy of Corticosteroid Therapy Versus Placebo in Fibrotic Hypersensitivity Pneumonitis": RUBY Study (Randomised Trial, glUcocorticoids Versus placeBo in Fibrotic hYpersensitivity Pneumonitis)
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.
Read the detailed description
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.
RUBY, is a national multicenter, randomized, double blind, placebo-controlled, superiority trial comparing the efficacy of prednisolone to placebo on the change in FVC (% pred) at 6 months.
The investigators will randomly assign participants (1:1 ratio, stratification according to the identification of an inciting antigen) to receive oral prednisolone or placebo for a period of 6 months with a follow-up of 12 months. The primary endpoint will be assessed at Month 6.
The investigators plan to include 120 participants.
- Conditions
- Hypersensitivity Pneumonitis
- Being tested
- Prednisolone, Placebo
- Medical subject headings
- Alveolitis, Extrinsic Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
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
PlaceboDrug
Dispersible placebo administered and tapered over 6 months according to the schedule detailed in the protocol
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Prednisolone |
| Placebo | Placebo comparator | Dispersible placebo administered and tapered over 6 months according to the schedule detailed in the protocol Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at month 6
Secondary outcomes (18)
Absolute change in FVC (% pred) according to the presence of a causal antigen at Month 6
Absolute change in FVC (% pred) from baseline (M0 or inclusion visit) to Month 6 according to the presence of a causal antigen.
Measured: at Month 6
The change in FVC (% pred) at 12 months (M12)
Absolute and relative changes in FVC (% pred) between M0 and M12 will be compared between the placebo arm and the prednisolone arm.
Measured: At month 12
The change in FVC (mL) at 12 months (M12)
Absolute and relative changes in FVC (mL) between M0 and M12 will be compared between the placebo arm and the prednisolone arm.
Measured: At month 12
The changes in DLco (mmol/min/kPa) at Month 6
Measured: At Month 6
The changes in DLco (% pred) at Month 6
Measured: At Month 6
The changes in DLco (mmol/min/kPa) at Month 12
Measured: At Month12
The changes in DLco (% pred) at Month 12
Measured: At Month 12
The changes in distance walked during six-minute walt test 6MWT in meters (m) at Month 12
Changes in distance walked during 6MWT (m) from Month 0 to Month12 will be compared between the placebo arm and the prednisolone arm
Measured: at Month12
The changes in distance walked during six-minute walt test 6MWT (% pred) at Month 12
Changes in distance walked during 6MWT (%pred) from Month 0 to Month12 will be compared between the placebo arm and the prednisolone arm
Measured: At Month 12
The changes in distance walked during six-minute walt test 6MWT in meters (m) at Month 6
Changes in distance walked during 6MWT (m) from Month 0 to Month 6 will be compared between the placebo arm and the prednisolone arm
Measured: At Month 6
The changes in distance walked during six-minute walt test 6MWT (%pred) at Month 6
Changes in distance walked during 6MWT (%pred) from Month 0 to Month 6 will be compared between the placebo arm and the prednisolone arm
Measured: At Month 6
The change in health related QoL (the Saint Georges Hospital Respiratory Questionnaire (SGRQ) at Month 6
Changes in Respiratory QoL (the Saint Georges Hospital Respiratory Questionnaire (SGRQ)) from Month 0 to Month 6 will be compared between the placebo arm and the prednisolone arm
Measured: At Month 6
The change in health related QoL (King's Brief ILD questionnaire) at Month 6
Changes in Respiratory QoL (King's Brief ILD questionnaire) from Month 0 to Month 6 will be compared between the placebo arm and the prednisolone arm
Measured: At Month 6
The change in health related QoL (the Saint Georges Hospital Respiratory Questionnaire (SGRQ) at Month 12
Changes in Respiratory QoL (the Saint Georges Hospital Respiratory Questionnaire (SGRQ)) from Month 0 to Month 12 will be compared between the placebo arm and the prednisolone arm
Measured: At Month 12
The change in health related QoL (King's Brief ILD questionnaire) at Month 12
Changes in Respiratory QoL (King's Brief ILD questionnaire) from Month 0 to Month 12 will be compared between the placebo arm and the prednisolone arm
Measured: At Month 12
The proportion of patients who develop pulmonary progressive fibrosis (PPF) within 12 months
Measured: Over 12 months
The proportion of subjects who experience acute exacerbation (AE) or require unplanned hospitalization within 12 months
Measured: Over 12 months
Progression free survival (PFS) at 12 months
Measured: At month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity PneumonitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucile SESE, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210008
- Sponsor's protocol ID
- APHP240908
- Other IDs
- 2025-521591-64-00, 2025
- Acronym
- RUBY
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Testing the Efficacy of Corticosteroid Therapy Versus Placebo in Fibrotic Hypersensitivity Pneumonitis": RUBY Study (Randomised Trial, glUcocorticoids Versus placeBo in Fibrotic hYpersensitivity Pneumonitis)
- ClinicalTrials.gov ID
- NCT07210008
- Acronym / sponsor ID
- RUBY / APHP240908
- Conditions
- Hypersensitivity Pneumonitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
RUBY, is a national multicenter, randomized, double blind, placebo-controlled, superiority trial comparing the efficacy of prednisolone to placebo on the change in FVC (% pred) at 6 months.
The investigators will randomly assign participants (1:1 ratio, stratification according to the identification of an inciting antigen) to receive oral prednisolone or placebo for a period of 6 months with a follow-up of 12 months. The primary endpoint will be assessed at Month 6.
The investigators plan to include 120 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone (oral) | Experimental | Drug: PrednisolonePrednisolone (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 |
| Placebo | Placebo comparator | Drug: PlaceboDispersible placebo administered and tapered over 6 months according to the schedule detailed in the protocol |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoloneActive 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 (oral) |
| PlaceboDispersible placebo administered and tapered over 6 months according to the schedule detailed in the protocol | Drug | Placebo |
Primary outcome
Absolute change in FVC (% pred)
Time frame: at month 6
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.
18 secondary outcomes
Absolute change in FVC (% pred) according to the presence of a causal antigen at Month 6
Time frame: at Month 6
The change in FVC (% pred) at 12 months (M12)
Time frame: At month 12
The change in FVC (mL) at 12 months (M12)
Time frame: At month 12
The changes in DLco (mmol/min/kPa) at Month 6
Time frame: At Month 6
The changes in DLco (% pred) at Month 6
Time frame: At Month 6
The changes in DLco (mmol/min/kPa) at Month 12
Time frame: At Month12
The changes in DLco (% pred) at Month 12
Time frame: At Month 12
The changes in distance walked during six-minute walt test 6MWT in meters (m) at Month 12
Time frame: at Month12
The changes in distance walked during six-minute walt test 6MWT (% pred) at Month 12
Time frame: At Month 12
The changes in distance walked during six-minute walt test 6MWT in meters (m) at Month 6
Time frame: At Month 6
The changes in distance walked during six-minute walt test 6MWT (%pred) at Month 6
Time frame: At Month 6
The change in health related QoL (the Saint Georges Hospital Respiratory Questionnaire (SGRQ) at Month 6
Time frame: At Month 6
The change in health related QoL (King's Brief ILD questionnaire) at Month 6
Time frame: At Month 6
The change in health related QoL (the Saint Georges Hospital Respiratory Questionnaire (SGRQ) at Month 12
Time frame: At Month 12
The change in health related QoL (King's Brief ILD questionnaire) at Month 12
Time frame: At Month 12
The proportion of patients who develop pulmonary progressive fibrosis (PPF) within 12 months
Time frame: Over 12 months
The proportion of subjects who experience acute exacerbation (AE) or require unplanned hospitalization within 12 months
Time frame: Over 12 months
Progression free survival (PFS) at 12 months
Time frame: At month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucile SESE study director
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisolone in people with Hypersensitivity Pneumonitis, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucile SESE (06 67 72 91 03, lucile.sese@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in FVC (% pred) (time frame: at month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.