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 ILD involves an interplay of inflammation and fibrosis, which can occur early in the disease course1,2

Q1: Nerandomilast is a preferential inhibitor of which key enzyme associated with inflammatory and fibrotic pathways?

Nerandomilast is an oral preferential inhibitor of PDE4B, with ~9-fold greater selectivity for PDE4B than for PDE4D3
In preclinical studies, nerandomilast showed anti-inflammatory and antifibrotic effects in in vitro and in vivo models of lung fibrosis3

Reference

ATP, adenosine triphosphate; ILD, interstitial lung disease; PDE, phosphodiesterase; TGF, transforming growth factor

  1. Distler J et al. Nat Rev Immunol 2019;15:705–30; 2. Wijsenbeek M, Cottin V. N Engl J Med 2020;383:958–68; 3. Herrmann FE et al. Front Pharmacol 2022;13:838449
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Nerandomilast is being evaluated in a Phase III clinical study in patients with PPF including those with autoimmune disease ILD1,2

Q2: What is the name of the study?

The FIBRONEER-ILD Phase III clinical trial program is evaluating the efficacy, safety and tolerability of nerandomilast in patients with PPF, including autoimmune disease ILD.1,2

Reference

PPF, progressive pulmonary fibrosis

  1. NCT05321082. Available at: https://clinicaltrials.gov (accessed April 2024)
  2. Maher TM et al. BMJ Open Respir Res 2023;10:e001580
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FIBRONEER-ILD will be conducted in more than 40 countries1

Q3: What is the primary endpoint of FIBRONEER™-ILD?

Primary endpoint2 • Absolute change from baseline in FVC (ml) at Week 52

Reference

FACIT, Functional Assessment of Chronic Illness Therapy; FVC, forced vital capacity; HAQ-DI, Health Assessment Questionnaire Disability Index; HRCT QILD-WL, high-resolution computed tomography quantitative interstitial lung disease-whole lung

  1. NCT05321082. Available at: https://clinicaltrials.gov (accessed April 2024)
  2. Maher TM et al. BMJ Open Respir Res 2023;10:e001580
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Nerandomilast is also being evaluated in patients with progressive fibrosing ILDs, including SSc-ILD, in the Phase III FIBRONEER™-ILD trial1,2

Q4: How many patients have been recruited to FIBRONEER™-ILD?

The FIBRONEER™-ILD trial is currently ongoing and fully recruited1 To be included in the trial, patients must have been diagnosed with a progressive fibrosing ILD other than IPF1 Patients (N=1178) are randomized 1:1:1 to receive nerandomilast (18 mg or 9 mg) or placebo1,2

Reference

ILD, interstitial lung disease; IPF, idiopathic pulmonary fibrosis; SSc-ILD, systemic sclerosis-associated interstitial lung disease

  1. NCT05321082. Available at: https://clinicaltrials.gov/study/NCT05321082 (accessed May 2024); 
  2. Maher TM et al. BMJ Open Respir Res 2023;10:e001580
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The primary endpoint of the FIBRONEER™-ILD trial is absolute change from baseline to Week 52 in FVC (mL)1,2

Q5: What is the key secondary endpoint of FIBRONEER™-ILD?

Other secondary outcomes include:1
Time to absolute decline in FVC (% predicted of >10) and DLCO (% predicted of >15%) from baseline
Absolute change from baseline in L-PF Symptoms scores (Dyspnea/Cough/Fatigue) at Week 52
Absolute change from baseline to Week 52 in FVC (% predicted) and DLCO (% predicted)

Reference

DLCO, diffusing capacity of the lungs for carbon monoxide; FVC, forced vital capacity; ILD, interstitial lung disease; L-PF, Living with Pulmonary Fibrosis

  1. NCT05321082. Available at: https://clinicaltrials.gov/study/NCT05321082 (accessed May 2024);
    Maher TM et al. BMJ Open Respir Res 2023;10:e001580
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sGC is an enzyme that triggers production of cGMP, a signaling molecule that regulates various processes implicated in SSc1–7

Q6: Which of these processes is not regulated by the key signaling molecule cGMP?

sGC binds nitric oxide to a prosthetic heme group and catalyzes production of cGMP.1,7 Oxidative stress (which plays a key role in inflammatory conditions such as SSc, kidney disease and cardiovascular disease) can negatively influence the production of cGMP by causing sGC to lose its heme group3, 6–9

Reference

cGMP, cyclic guanosine monophosphate; sGC, soluble guanylate cyclase; SSc, systemic sclerosis

  1. Das Gupta A et al. Clin Pharmacol Ther 2015;97:88–102;
  2. Sandner P et al. Respir Med 2017;122:S1–9;
  3. Tsai EJ et al. Pharmacol Ther 2009;122:216–38;
  4. Yamamoto K et al. Int J Cardiol 2020;299:263–70;
  5. Romano E et al. Rheumatology (Oxford) 2023;62:SI125–37;
  6. Stasch JP et al. Circulation 2011;123:2263-2273;
  7. Nabozny G et al. Ann Rheum Dis 2023;82:583–4;
  8. Reinhart GA et al. J Pharmacol Exp Ther 2023;384:352–92;
  9. Cachofeiro V et al. Kidney Int Suppl 2003;111:S4–9
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sGC stimulators and activators have been identified, which restore cGMP production through differing mechanisms1

Q7: Which of the following best describes the mode of action of avenciguat?

In preclinical studies, treatment with avenciguat led to activation of heme-free sGC, increased cGMP levels in vitro and antifibrotic effects in vivo1

Reference

cGMP, cyclic guanosine monophosphate; sGC, soluble guanylate cyclase

  1. Reinhart GA et al. J Pharmacol Exp Ther 2023;384:382–92
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VITALISScE™ is a Phase II trial of avenciguat that is currently enrolling patients1

Q8: Which population is included in VITALISScE™?

VITALISScE™ is a Phase II trial of avenciguat in patients with progressive SSc1 The study aims to enroll 200 patients who will be randomized to treatment with avenciguat or placebo1

Reference

ILD, interstitial lung disease; IPF, idiopathic pulmonary fibrosis; SSc, systemic sclerosis; SSc-ILD, systemic sclerosis-associated interstitial lung disease

  1. NCT05559580. Available at: https://clinicaltrials.gov/ct2/show/NCT05559580 (accessed May 2024)
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The VITALISScE™ study will evaluate the safety and efficacy of avenciguat in patients with progressive SSc1

Q9: What is the primary endpoint of VITALISScE™?

Primary endpoint1

  • Rate of decline from baseline to Week 48 in FVC (mL) 

Key Secondary endpoints1

  • Absolute change from baseline to Week 48 in mRSS in patients with dcSSc
  • Proportion of responders per revised CRISS at Week 48 in patients with dcSSc
  • Absolute change from baseline to Week 48 in HAQ-DI  

Reference

CRISS, Composite Response Index in Systemic Sclerosis; dcSSc, diffuse cutaneous systemic sclerosis; FVC, forced vital capacity; HAQ-DI, Health Assessment Questionnaire Disability Index; mRSS, modified Rodnan skin score; SSc, systemic sclerosis

  1. NCT05559580. Available at: https://clinicaltrials.gov/ct2/show/NCT05559580 (accessed May 2024)
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Boehringer is supporting the cross-sectional screening study ANCHOR-RA1

Q10: What approach is this study taking to screen for ILD in patients with RA?

ANCHOR-RA1 is exploring a risk factor-guided approach to ILD screening in patients with RA. Patients must have ≥2 of the following ILD risk factors:1

  • Male
  • Current or previous smoker
  • Aged ≥60 years at RA diagnosis
  • RF positive and/or anti-CCP high-positive level (titer >3x ULN) at or any time after RA diagnosis
  • High RA disease activity score at or within 12 months of screening visit 
  • Presence or history of Vasculitis/Felty’s syndrome/secondary Sjögren’s syndrome, cutaneous rheumatoid nodules, serositis and/or scleritis/uveitis

Reference

CCP, cyclic citrullinated peptide; ILD, interstitial lung disease; RA rheumatoid arthritis; ULN, upper limit of normal

  1. Sparks JA et al. BMC Rheumatology 2024;8:19

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